{"updatedAt":"2026-10-12T07:11:38.881Z","source":"FDA CDER novel drug approvals + openFDA","count":142,"drugs":[{"slug":"hovilpri","brand":"Hovilpri","generic":"pritelivir","date":"2026-10-09","year":2026,"use":"To treat adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapies","fdaLink":null,"category":"infectious-disease","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:28.581Z"},{"slug":"emcitate","brand":"Emcitate","generic":"tiratricol","date":"2026-09-28","year":2026,"use":"To treat peripheral thyrotoxicosis in patients with MCT8 deficiency","fdaLink":null,"category":"rare-genetic","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:28.742Z"},{"slug":"juvmo","brand":"Juvmo","generic":"tavapadon","date":"2026-09-25","year":2026,"use":"To treat Parkinson’s disease in adults","fdaLink":null,"category":"neurology-psychiatry","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:29.319Z"},{"slug":"atebrioz","brand":"Atebrioz","generic":"zilurgisertib","date":"2026-09-25","year":2026,"use":"To reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva","fdaLink":null,"category":"rare-genetic","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:28.904Z"},{"slug":"onswik","brand":"Onswik","generic":"insulin efsitora alfa-gobe","date":"2026-09-23","year":2026,"use":"To improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise","fdaLink":null,"category":"weight-loss-diabetes","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:29.648Z"},{"slug":"lyrfigtu","brand":"Lyrfigtu","generic":"lirafugratinib","date":"2026-09-23","year":2026,"use":"To adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangement","fdaLink":null,"category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:29.484Z"},{"slug":"isembyld","brand":"Isembyld","generic":"apitegromab-mstn","date":"2026-09-11","year":2026,"use":"To treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment","fdaLink":null,"category":"neurology-psychiatry","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:29.954Z"},{"slug":"pixclara","brand":"Pixclara","generic":"floretyrosine F 18","date":"2026-09-11","year":2026,"use":"To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluations","fdaLink":null,"category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:29.800Z"},{"slug":"etcamah","brand":"Etcamah","generic":"camizestrant","date":"2026-09-04","year":2026,"use":"To treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy","fdaLink":null,"category":"cancer","sponsor":"ASTRAZENECA","applicationNumber":"NDA220359","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration ( 2.1 )] . This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of","boxedWarning":true,"setId":"c54223d3-f3c7-4186-afa0-429d84805826","enrichedAt":"2026-10-11T19:24:30.217Z"},{"slug":"zanvastro","brand":"Zanvastro","generic":"zilganersen","date":"2026-09-03","year":2026,"use":"To treat Alexander disease in pediatric and adult patients","fdaLink":null,"category":"neurology-psychiatry","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:30.373Z"},{"slug":"mimrylo","brand":"Mimrylo","generic":"rusfertide","date":"2026-08-28","year":2026,"use":"To treat erythrocytosis in adults with polycythemia vera","fdaLink":null,"category":"heart-blood","sponsor":"TAKEDA PHARMS AM","applicationNumber":"NDA220605","dosageForm":"POWDER","route":"SUBCUTANEOUS","pharmClass":null,"indications":"MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )","boxedWarning":false,"setId":"101aff01-31ed-4841-a8b6-0a5a8503189b","enrichedAt":"2026-10-11T19:24:30.628Z"},{"slug":"lisraya","brand":"Lisraya","generic":"brepocitinib","date":"2026-08-27","year":2026,"use":"To treat dermatomyositis in adults","fdaLink":null,"category":"immunology","sponsor":"PRIOVANT THERAP","applicationNumber":"NDA220106","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"LISRAYA is indicated for the treatment of dermatomyositis in adult patients. LISRAYA is a Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of dermatomyositis in adult patients. ( 1 ) Limitations of Use LISRAYA is not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs. Limitations of Use LISRAYA is not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.","boxedWarning":true,"setId":"5023a17b-e96a-67d4-e063-6394a90a14a7","enrichedAt":"2026-10-11T19:24:30.874Z"},{"slug":"rasonque","brand":"Rasonque","generic":"daraxonrasib","date":"2026-08-26","year":2026,"use":"To treat metastatic pancreatic cancer","fdaLink":null,"category":"cancer","sponsor":"REVOLUTION MEDICINES","applicationNumber":"NDA220910","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. RASONQUE is an inhibitor of the RAS GTPase family, indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. ( 1 )","boxedWarning":false,"setId":"13a65923-d072-4dac-8620-8eabbf8c3641","enrichedAt":"2026-10-11T19:24:31.043Z"},{"slug":"pasatru","brand":"Pasatru","generic":"garetosmab-grts","date":"2026-08-19","year":2026,"use":"To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva","fdaLink":null,"category":"rare-genetic","sponsor":"REGENERON PHARMACEUTICALS, INC","applicationNumber":"BLA761508","dosageForm":"INJECTABLE","route":"INTRAVENOUS","pharmClass":null,"indications":"PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). PASATRU is an activin signaling inhibitor indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). ( 1 )","boxedWarning":false,"setId":"0d5cec96-b02b-4f1d-bc66-51e62ce04e3c","enrichedAt":"2026-10-11T19:24:31.210Z"},{"slug":"tauklarify","brand":"Tauklarify","generic":"florquinitau F 18","date":"2026-08-13","year":2026,"use":"To be used for positron emission tomography of the brain in adults with cognitive impairment who are being evaluated for Alzheimer disease to identify patients with tau neurofibrillary tangle pathology","fdaLink":null,"category":"neurology-psychiatry","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:31.546Z"},{"slug":"zenbexus","brand":"Zenbexus","generic":"iberdomide","date":"2026-08-13","year":2026,"use":"To be used in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent","fdaLink":null,"category":"cancer","sponsor":"BRISTOL MYERS SQUIBB","applicationNumber":"NDA221075","dosageForm":"CAPSULE","route":"ORAL","pharmClass":null,"indications":"ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete response (CR) at any time [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZENBEXUS is a cereblon-modulating protein degrader indicated in combination with daratumumab and hyaluronidase-fihj and d","boxedWarning":true,"setId":"3663d9cb-3f66-48ae-bf0a-6958bc0888de","enrichedAt":"2026-10-11T19:24:31.387Z"},{"slug":"orzeyful","brand":"Orzeyful","generic":"oveporexton","date":"2026-08-05","year":2026,"use":"To treat narcolepsy type 1","fdaLink":null,"category":"other","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:31.894Z"},{"slug":"lytenava","brand":"Lytenava","generic":"bevacizumab-vikg","date":"2026-07-24","year":2026,"use":"To treat patients with neovascular (wet) age-related macular degeneration","fdaLink":null,"category":"eye","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:32.243Z"},{"slug":"simtriyo","brand":"Simtriyo","generic":"centanafadine","date":"2026-07-24","year":2026,"use":"To treat attention-deficit hyperactivity disorder","fdaLink":null,"category":"rare-genetic","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:32.077Z"},{"slug":"jideytro","brand":"Jideytro","generic":"zidesamtinib","date":"2026-07-22","year":2026,"use":"To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitor","fdaLink":null,"category":"cancer","sponsor":"NUVALENT","applicationNumber":"NDA220185","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"JIDEYTRO is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor [see Dosage and Administration ( 2.1 ), Clinical Studies ( 14.1 )] . JIDEYTRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received a prior ROS1 kinase inhibitor.( 1 )","boxedWarning":false,"setId":"3760e421-b523-4d9b-e063-6394a90ab94b","enrichedAt":"2026-10-11T19:24:32.546Z"},{"slug":"lipfendra","brand":"Lipfendra","generic":"enlicitide decanoate","date":"2026-07-15","year":2026,"use":"To reduce low-density lipoprotein cholesterol","fdaLink":null,"category":"heart-blood","sponsor":"MSD","applicationNumber":"NDA220848","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"LIPFENDRA ® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy. LIPFENDRA is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in a","boxedWarning":false,"setId":"100ec543-fbd0-44fc-b740-db9cdff39145","enrichedAt":"2026-10-11T19:24:32.700Z"},{"slug":"revtorpyk","brand":"Revtorpyk","generic":"gedatolisib","date":"2026-07-14","year":2026,"use":"In combination with fulvestran, to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting","fdaLink":null,"category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:32.860Z"},{"slug":"trutakna","brand":"Trutakna","generic":"atacicept-vymj","date":"2026-07-07","year":2026,"use":"To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression","fdaLink":null,"category":"kidney-liver-lung","sponsor":"VERA THERAPEUTICS INC.","applicationNumber":"BLA761486","dosageForm":"INJECTABLE","route":"SUBCUTANEOUS","pharmClass":null,"indications":"TRUTAKNA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. TRUTAKNA is a B-lymphocyte stimulator (BLyS)-specific inhibitor and A Proliferation Inducing Ligand (APRIL) blocker indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at ri","boxedWarning":false,"setId":"24aa29f6-ccff-45d3-89af-4d26e525cef8","enrichedAt":"2026-10-11T19:24:33.033Z"},{"slug":"lumvoa","brand":"Lumvoa","generic":"veligrotug-vvze","date":"2026-06-26","year":2026,"use":"To treat thyroid eye disease","fdaLink":null,"category":"eye","sponsor":"VIRIDIAN THERAPEUTICS INC","applicationNumber":"BLA761530","dosageForm":"INJECTION","route":null,"pharmClass":null,"indications":"LUMVOA is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. LUMVOA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. ( 1 )","boxedWarning":false,"setId":"11bc286a-5411-45af-af3f-69ad38efb610","enrichedAt":"2026-10-11T19:24:33.199Z"},{"slug":"utebzi","brand":"Utebzi","generic":"tebipenem pivoxil","date":"2026-06-17","year":2026,"use":"To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options","fdaLink":null,"category":"infectious-disease","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:33.362Z"},{"slug":"ambelvist","brand":"Ambelvist","generic":"gadoquatrane","date":"2026-06-12","year":2026,"use":"To detect and visualize lesions with abnormal vascularity, in conjunction with MRI","fdaLink":null,"category":"diagnostic-imaging","sponsor":"BAYER HEALTHCARE","applicationNumber":"NDA219627","dosageForm":"SOLUTION","route":"INTRAVENOUS","pharmClass":null,"indications":"AMBELVIST is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) AMBELVIST is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) ","boxedWarning":true,"setId":"fac80f5d-8d37-4237-bb52-0faef0dd46aa","enrichedAt":"2026-10-11T19:24:33.526Z"},{"slug":"zaynich","brand":"Zaynich","generic":"cefepime and zidebactam","date":"2026-05-29","year":2026,"use":"To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms","fdaLink":null,"category":"infectious-disease","sponsor":"WOCKHARDT BIO AG","applicationNumber":"NDA220787","dosageForm":"POWDER","route":"INTRAVENOUS","pharmClass":null,"indications":"ZAYNICH is a combination of cefepime, a cephalosporin antibacterial, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Complicated Urinary Tract Infections, including Pyelonephriti","boxedWarning":false,"setId":"c84e652e-5e76-4568-8812-bd5fa34803b6","enrichedAt":"2026-10-11T19:24:34.024Z"},{"slug":"xocova","brand":"Xocova","generic":"ensitrelvir","date":"2026-05-29","year":2026,"use":"To use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19","fdaLink":null,"category":"infectious-disease","sponsor":"SHIONOGI","applicationNumber":"NDA220442","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"XOCOVA is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA, a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease (M pro : also referred to as 3CL pro or nsp5 protease) inhibitor, is indicated for post-exposure prophylaxis of coronavirus disease 2019 (COVID‑19) in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. ( 1 )","boxedWarning":false,"setId":"526acf60-abc3-2cc2-e063-6294a90affa6","enrichedAt":"2026-10-11T19:24:33.859Z"},{"slug":"cypsedo","brand":"Cypsedo","generic":"cipepofol","date":"2026-05-29","year":2026,"use":"To induce general anesthesia in adults undergoing surgery","fdaLink":null,"category":"pain-anesthesia","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:33.686Z"},{"slug":"decnupaz","brand":"Decnupaz","generic":"pivekimab sunirine-pvzy","date":"2026-05-27","year":2026,"use":"To treat adults with blastic plasmacytoid dendritic cell neoplasm","fdaLink":null,"category":"cancer","sponsor":"ABBVIE INC","applicationNumber":"BLA761460","dosageForm":"VIAL","route":"SINGLE-DOSE","pharmClass":null,"indications":"1. INDICATIONS AND USAGE DECNUPAZ is indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). DECNUPAZ is a CD123-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). ( 1 )","boxedWarning":true,"setId":"508b6ff8-601d-4901-a7a5-816141134054","enrichedAt":"2026-10-11T19:24:34.191Z"},{"slug":"hepcludex","brand":"Hepcludex","generic":"bulevirtide-gmod","date":"2026-05-22","year":2026,"use":"To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis","fdaLink":null,"category":"infectious-disease","sponsor":"GILEAD SCIENCES INC","applicationNumber":"BLA761468","dosageForm":"INJECTION","route":"POWDER,FOR SOLUTION","pharmClass":null,"indications":"HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14) ] . An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults w","boxedWarning":true,"setId":"12391cc2-38c2-4cf5-86d3-2be9370127fc","enrichedAt":"2026-10-11T19:24:34.383Z"},{"slug":"baxfendy","brand":"Baxfendy","generic":"baxdrostat","date":"2026-05-15","year":2026,"use":"To treat hypertension in combination with other antihypertensive drugs","fdaLink":null,"category":"heart-blood","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:34.538Z"},{"slug":"beqalzi","brand":"Beqalzi","generic":"sonrotoclax","date":"2026-05-13","year":2026,"use":"To treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor","fdaLink":null,"category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:34.715Z"},{"slug":"veppanu","brand":"Veppanu","generic":"vepdegestrant","date":"2026-05-01","year":2026,"use":"To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy","fdaLink":null,"category":"cancer","sponsor":"RIGEL PHARMS","applicationNumber":"NDA219835","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1) -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU is a heterobifunctional protein degrader indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1) -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine ther","boxedWarning":false,"setId":"484e21ba-8fe1-4c6d-b923-8ba4cf5b2f20","enrichedAt":"2026-10-11T19:24:34.886Z"},{"slug":"idvynso","brand":"Idvynso","generic":"doravirine and islatravir","date":"2026-04-20","year":2026,"use":"To treat HIV-1 infection (as a complete regimen) in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine","fdaLink":null,"category":"infectious-disease","sponsor":"MSD","applicationNumber":"NDA216964","dosageForm":"TABLET","route":"ORAL","pharmClass":"Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]","indications":"IDVYNSO™ is indicated as a complete two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine [see Microbiology (12.4) and Clinical Studies (14) ]. IDVYNSO is a two-drug combination of doravirine, a HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI), and islatravir, a nucleoside analog reverse transcriptase inhibitor (NRTI), and is indicated as a complete regimen for the","boxedWarning":false,"setId":"11aaeb53-9848-433c-be7f-db8a5bc0b26f","enrichedAt":"2026-10-11T19:24:35.067Z"},{"slug":"foundayo","brand":"Foundayo","generic":"orforglipron","date":"2026-04-01","year":2026,"use":"To reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition, in combination with a reduced-calorie diet and increased physical activity","fdaLink":null,"category":"weight-loss-diabetes","sponsor":"ELI LILLY AND CO","applicationNumber":"NDA220934","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"FOUNDAYO TM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. FOUNDAYO™ is a GLP-1 receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use Concomitant use with another GLP-1 receptor agonist is not recommended. ( 1 ) Limi","boxedWarning":true,"setId":"8ac446c5-feba-474f-a103-23facb9b5c62","enrichedAt":"2026-10-11T19:24:35.236Z"},{"slug":"awiqli","brand":"Awiqli","generic":"insulin icodec-abae","date":"2026-03-26","year":2026,"use":"To improve glycemic control in adults with type 2 diabetes mellitus","fdaLink":null,"category":"weight-loss-diabetes","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:24:35.406Z"},{"slug":"lifyorli","brand":"Lifyorli","generic":"relacorilant","date":"2026-03-25","year":2026,"use":"To treat platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic treatment regimens, at least one of which included bevacizumab","fdaLink":null,"category":"cancer","sponsor":"CORCEPT THERAP","applicationNumber":"NDA220641","dosageForm":"CAPSULE","route":"ORAL","pharmClass":null,"indications":"LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. ( 1 , 14 )","boxedWarning":false,"setId":"6fcebfb5-19d6-4f63-b852-999d68a13729","enrichedAt":"2026-10-11T19:24:35.574Z"},{"slug":"avlayah","brand":"Avlayah","generic":"tividenofusp alfa-eknm","date":"2026-03-24","year":2026,"use":"To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)","fdaLink":null,"category":"rare-genetic","sponsor":"DENALI THERAPEUTICS INC.","applicationNumber":"BLA761485","dosageForm":"INJECTION","route":"POWDER,FOR SOLUTION","pharmClass":"Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]","indications":"AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome. AVLAYAH ","boxedWarning":true,"setId":"014d92c1-b643-4680-8ca6-f0b3307da915","enrichedAt":"2026-10-11T19:24:35.729Z"},{"slug":"lynavoy","brand":"Lynavoy","generic":"linerixibat","date":"2026-03-17","year":2026,"use":"To treat cholestatic pruritus associated with primary biliary cholangitis","fdaLink":null,"category":"kidney-liver-lung","sponsor":"INTERCEPT","applicationNumber":"NDA220295","dosageForm":"TABLET","route":"ORAL","pharmClass":"Ileal Bile Acid Transporter Inhibitor [EPC]","indications":"LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . LYNAVOY is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. ( 1 ) Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or act","boxedWarning":false,"setId":"c00317c8-709c-4707-a6d1-632bff123026","enrichedAt":"2026-10-11T19:26:40.191Z"},{"slug":"icotyde","brand":"Icotyde","generic":"icotrokinra","date":"2026-03-17","year":2026,"use":"To treat moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy","fdaLink":null,"category":"immunology","sponsor":"JANSSEN BIOTECH","applicationNumber":"NDA220149","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ICOTYDE is an interleukin-23 (IL-23) receptor antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy. ( 1 )","boxedWarning":false,"setId":"aee3c963-edc0-4252-8769-cdf6c7cdc21a","enrichedAt":"2026-10-11T19:24:35.902Z"},{"slug":"yuviwel","brand":"Yuviwel","generic":"navepegritide","date":"2026-02-27","year":2026,"use":"To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses","fdaLink":null,"category":"rare-genetic","sponsor":"ASCENDIS","applicationNumber":"NDA219164","dosageForm":"POWDER","route":"SUBCUTANEOUS","pharmClass":null,"indications":"YUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. ( 1 ) This indication is approved under accelerated approval based on an improvement in annualized growth velo","boxedWarning":false,"setId":"e01c1197-338f-414c-b804-808e129ebc8c","enrichedAt":"2026-10-11T19:26:40.530Z"},{"slug":"loargys","brand":"Loargys","generic":"pegzilarginase-nbln","date":"2026-02-23","year":2026,"use":"To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction","fdaLink":null,"category":"rare-genetic","sponsor":"IMMEDICA PHARMA AB","applicationNumber":"BLA761211","dosageForm":"Injectable","route":"Injection","pharmClass":null,"indications":"LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. This indication is approved under accelerated approval based on reduction of plasma arginine [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. LOARGYS is an arginine specific enzyme indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Arginase 1 Deficiency (ARG1-D), in conjunction with dietary protein restriction. ( 1 ) T","boxedWarning":true,"setId":"d5ceabf2-43a0-4746-9371-d98a39cf6cfc","enrichedAt":"2026-10-11T19:26:40.684Z"},{"slug":"bysanti","brand":"Bysanti","generic":"milsaperidone","date":"2026-02-20","year":2026,"use":"To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder","fdaLink":null,"category":"neurology-psychiatry","sponsor":"VANDA PHARMS INC","applicationNumber":"NDA220358","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"BYSANTI ™ is indicated for the: Treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies (14.2) ] . BYSANTI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 , 14.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. ( 1 , 14.2 )","boxedWarning":true,"setId":"254a1c01-4a4c-4bdd-85d6-1f23f2e4e6f8","enrichedAt":"2026-10-11T19:26:41.091Z"},{"slug":"adquey","brand":"Adquey","generic":"difamilast","date":"2026-02-12","year":2026,"use":"To treat mild to moderate atopic dermatitis","fdaLink":null,"category":"immunology","sponsor":"ACROTECH BIOPHARMA","applicationNumber":"NDA219474","dosageForm":"OINTMENT","route":"TOPICAL","pharmClass":"Phosphodiesterase 4 Inhibitor [EPC]","indications":"1 INDICATIONS & USAGE ADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. ADQUEY is a phosphodiesterase 4 inhibitor indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. (1)","boxedWarning":false,"setId":"46c95e41-fa29-4e11-9d94-0fd4f0291c34","enrichedAt":"2026-10-11T19:26:41.244Z"},{"slug":"zycubo","brand":"Zycubo","generic":"copper histidinate","date":"2026-01-12","year":2026,"use":"To treat Menkes disease","fdaLink":null,"category":"rare-genetic","sponsor":"SENTYNL THERAPS INC","applicationNumber":"NDA211241","dosageForm":"POWDER","route":"SUBCUTANEOUS","pharmClass":null,"indications":"ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicated for the treatment of Menkes disease in pediatric patients. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome. ( 1 ) Limitations of Use ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.","boxedWarning":false,"setId":"e3aeefc2-f44d-4337-9c2e-3dba44a89e48","enrichedAt":"2026-10-11T19:26:41.397Z"},{"slug":"nereus","brand":"Nereus","generic":"tradipitant","date":"2025-12-30","year":2025,"use":"To treat vomiting associated with motion","fdaLink":null,"category":"other","sponsor":"VANDA PHARMS INC","applicationNumber":"NDA220152","dosageForm":"CAPSULE","route":"ORAL","pharmClass":null,"indications":"NEREUS is indicated for the prevention of vomiting induced by motion in adults. NEREUS is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of vomiting induced by motion in adults. ( 1 )","boxedWarning":false,"setId":"1a021ebd-16ac-4354-b4b2-1c3950c091e5","enrichedAt":"2026-10-11T19:29:15.269Z"},{"slug":"yartemlea","brand":"Yartemlea","generic":"narsoplimab-wuug","date":"2025-12-23","year":2025,"use":"To treat hematopoietic stem cell transplant-associated thrombotic microangiopathy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761152Orig1s000lbl.pdf","category":"immunology","sponsor":"OMEROS CORP","applicationNumber":"BLA761152","dosageForm":"INJECTION","route":null,"pharmClass":null,"indications":"YARTEMLEA is indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). YARTEMLEA is a MASP-2 inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA). ( 1 )","boxedWarning":false,"setId":"f8ff990a-0d2e-433f-9615-b9b097448991","enrichedAt":"2026-10-11T19:29:15.413Z"},{"slug":"myqorzo","brand":"Myqorzo","generic":"aficamten","date":"2025-12-19","year":2025,"use":"To treat symptomatic obstructive hypertrophic cardiomyopathy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219083s000lbl.pdf","category":"heart-blood","sponsor":"CYTOKINETICS","applicationNumber":"NDA219083","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. MYQORZO is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. ( 1 )","boxedWarning":true,"setId":"fd778507-1274-4d1a-a659-5431d55c543a","enrichedAt":"2026-10-11T19:29:15.561Z"},{"slug":"exdensur","brand":"Exdensur","generic":"depemokimab-ulaa","date":"2025-12-16","year":2025,"use":"To treat severe asthma characterized by an eosinophilic phenotype as an Komziftiadd-on maintenance therapy","fdaLink":null,"category":"immunology","sponsor":"GLAXOSMITHKLINE LLC","applicationNumber":"BLA761458","dosageForm":"INJECTION","route":null,"pharmClass":null,"indications":"EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . EXDENSUR is an interleukin‑5 (IL‑5) antagonist, a monoclonal antibody (humanized immunoglobulin G1 [IgG1] kappa) indicated for add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. ( 1 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. ( 1 )","boxedWarning":false,"setId":"30332b20-2ac0-42ad-a775-d3ca7f5fe29f","enrichedAt":"2026-10-11T19:29:15.731Z"},{"slug":"lerochol","brand":"Lerochol","generic":"lerodalcibep-liga","date":"2025-12-12","year":2025,"use":"To reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exercise","fdaLink":"https://www.drugs.com/pro/lerochol.html","category":"heart-blood","sponsor":"LIB THERAPEUTICS, INC.","applicationNumber":"BLA761427","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":null,"indications":"LEROCHOL TM is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). LEROCHOL is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). ( 1 )","boxedWarning":false,"setId":"422f8b04-6ce8-4e64-a0a9-0ccc9a4a5860","enrichedAt":"2026-10-11T19:29:16.167Z"},{"slug":"nuzolvence","brand":"Nuzolvence","generic":"zoliflodacin","date":"2025-12-12","year":2025,"use":"To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae","fdaLink":null,"category":"infectious-disease","sponsor":"ENTASIS THERAP","applicationNumber":"NDA219491","dosageForm":"FOR SUSPENSION","route":"ORAL","pharmClass":null,"indications":"NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Uncomplicated Urogenital Gonorrhea NUZOLVENCE is indicated for the treatment of uncomplicated urogenital gonor","boxedWarning":false,"setId":"4beda35a-21b0-4b34-84ea-be6ea8cae50f","enrichedAt":"2026-10-11T19:29:16.022Z"},{"slug":"cardamyst","brand":"Cardamyst","generic":"etripamil","date":"2025-12-12","year":2025,"use":"To treat episodes of paroxysmal supraventricular tachycardia","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218571s000lbl.pdf","category":"heart-blood","sponsor":"MILESTONE PHARMS USA","applicationNumber":"NDA218571","dosageForm":"SPRAY","route":"NASAL","pharmClass":null,"indications":"CARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. CARDAMYST is a calcium channel blocker indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults ( 1 ).","boxedWarning":false,"setId":"a92170b9-4f93-4b83-b2cd-cb85c52821cd","enrichedAt":"2026-10-11T19:29:15.876Z"},{"slug":"voyxact","brand":"Voyxact","generic":"sibeprenlimab-szsi","date":"2025-11-25","year":2025,"use":"To reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progression","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761434s000lbl.pdf","category":"kidney-liver-lung","sponsor":"OTSUKA PHARM CO LTD","applicationNumber":"BLA761434","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":null,"indications":"VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VOYXACT is an A Proliferation Inducing Ligand (APRIL) blocker, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. ( 1 ) This indication is ap","boxedWarning":false,"setId":"c8a93b32-0676-4704-86dc-cb65f425c6e5","enrichedAt":"2026-10-11T19:29:16.353Z"},{"slug":"hyrnuo","brand":"Hyrnuo","generic":"sevabertinib","date":"2025-11-19","year":2025,"use":"To treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219972s000lblCorrected.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:29:16.492Z"},{"slug":"redemplo","brand":"Redemplo","generic":"plozasiran","date":"2025-11-18","year":2025,"use":"To reduce triglycerides in adults with familial chylomicronemia syndrome","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219947s000lbl.pdf","category":"weight-loss-diabetes","sponsor":"ARROWHEAD","applicationNumber":"NDA219947","dosageForm":"SOLUTION","route":"SUBCUTANEOUS","pharmClass":"APOC-III-directed RNA Interaction [EPC]","indications":"REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). REDEMPLO is an apolipoprotein C-III ( apoC-III )-directed small interfering ribonucleic acid (siRNA) indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). ( 1 )","boxedWarning":false,"setId":"7fd37993-f85a-4af1-8bbe-133299f226ed","enrichedAt":"2026-10-11T19:29:16.643Z"},{"slug":"komzifti","brand":"Komzifti","generic":"ziftomenib","date":"2025-11-13","year":2025,"use":"To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/220305s000lbl.pdf","category":"cancer","sponsor":"KURA","applicationNumber":"NDA220305","dosageForm":"CAPSULE","route":"ORAL","pharmClass":"Menin Inhibitor [EPC]","indications":"KOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14 )] . KOMZIFTI is a menin inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options. ( 1 )","boxedWarning":true,"setId":"b650f696-3391-4274-8b55-a5f5e9d04769","enrichedAt":"2026-10-11T19:29:16.797Z"},{"slug":"kygevvi","brand":"Kygevvi","generic":"doxecitine and doxribtimine","date":"2025-11-03","year":2025,"use":"To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or younger","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219792s000lbl.pdf","category":"rare-genetic","sponsor":"UCB INC","applicationNumber":"NDA219792","dosageForm":"FOR SOLUTION","route":"ORAL","pharmClass":null,"indications":"KYGEVVI is indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. KYGEVVI is a combination of doxecitine and doxribtimine, both pyrimidine nucleosides, indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. ( 1 )","boxedWarning":false,"setId":"7d5ce670-9314-4fd7-8b0a-1447910dcf9e","enrichedAt":"2026-10-11T19:29:16.946Z"},{"slug":"lynkuet","brand":"Lynkuet","generic":"elinzanetant","date":"2025-10-24","year":2025,"use":"To treat moderate-to-severe vasomotor symptoms due to menopause","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf","category":"womens-health","sponsor":"BAYER HLTHCARE","applicationNumber":"NDA219469","dosageForm":"CAPSULE","route":"ORAL","pharmClass":null,"indications":"LYNKUET is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. LYNKUET is a neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause. ( 1 )","boxedWarning":false,"setId":"f42884ff-7dff-419c-8a0c-affe2ed73818","enrichedAt":"2026-10-11T19:29:17.133Z"},{"slug":"jascayd","brand":"Jascayd","generic":"nerandomilast","date":"2025-10-07","year":2025,"use":"To treat idiopathic pulmonary fibrosis","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218764s000lbl.pdf","category":"kidney-liver-lung","sponsor":"BOEHRINGER INGELHEIM","applicationNumber":"NDA218764","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"JASCAYD is a phosphodiesterase 4 (PDE4) inhibitor indicated for: The treatment of idiopathic pulmonary fibrosis in adult patients. ( 1.1 ) The treatment of progressive pulmonary fibrosis in adult patients. ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis JASCAYD is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) in adult patients. 1.2 Progressive Pulmonary Fibrosis JASCAYD is indicated for the treatment of progressive pulmonary fibrosis (PPF) in adult patients.","boxedWarning":false,"setId":"fa1b14c6-957f-d326-5099-911bfe33e391","enrichedAt":"2026-10-11T19:29:18.209Z"},{"slug":"rhapsido","brand":"Rhapsido","generic":"remibrutinib","date":"2025-09-30","year":2025,"use":"To treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatment","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218436s000lbl.pdf","category":"immunology","sponsor":"NOVARTIS","applicationNumber":"NDA218436","dosageForm":"TABLET","route":"ORAL","pharmClass":"Kinase Inhibitor [EPC]","indications":"RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria. RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. ( 1 ) Limitations of Use: Not indicated for other forms of urticaria. ( 1 )","boxedWarning":false,"setId":"e5e89bff-6ced-4165-acc5-fb13136b3a3d","enrichedAt":"2026-10-11T19:29:18.354Z"},{"slug":"inluriyo","brand":"Inluriyo","generic":"imlunestrant","date":"2025-09-25","year":2025,"use":"To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218881s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:29:18.636Z"},{"slug":"palsonify","brand":"Palsonify","generic":"paltusotine","date":"2025-09-25","year":2025,"use":"To treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an option","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219070s000lbl.pdf","category":"womens-health","sponsor":"CRINETICS","applicationNumber":"NDA219070","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"PALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option ( 1 ).","boxedWarning":false,"setId":"8a6d2ce0-a621-4ee7-983c-977cd948ff4d","enrichedAt":"2026-10-11T19:29:18.498Z"},{"slug":"keytruda-qlex","brand":"Keytruda Qlex","generic":"pembrolizumab and berahyaluronidase alfa-pmph","date":"2025-09-19","year":2025,"use":"To treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig2.pdf","category":"cancer","sponsor":"MERCK SHARP DOHME","applicationNumber":"BLA761467","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":"Endoglycosidase [EPC]","indications":"KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection. ( 1.1 ) Non-Small Cell Lung Cancer (NSCLC) in combination with pemetrexed and platinum chemotherapy, as first-line treatment of adult patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.2 ) in combination with carboplatin and either paclitaxel or paclit","boxedWarning":false,"setId":"097d166f-b73b-41d3-9b37-7653cd2a0c41","enrichedAt":"2026-10-11T19:29:19.077Z"},{"slug":"forzinity","brand":"Forzinity","generic":"elamipretide","date":"2025-09-19","year":2025,"use":"To improve muscle strength in patients with Barth syndrome weighing at least 30 kg","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215244s000lbl.pdf","category":"rare-genetic","sponsor":"STEALTH BIOTHERAPS","applicationNumber":"NDA215244","dosageForm":"SOLUTION","route":"SUBCUTANEOUS","pharmClass":null,"indications":"FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. ( 1 ) This indication is approved under accelerated approval based on an improvement in knee ext","boxedWarning":false,"setId":"146bf34c-76f2-48db-ac07-fb29cce2cd75","enrichedAt":"2026-10-11T19:29:18.782Z"},{"slug":"wayrilz","brand":"Wayrilz","generic":"rilzabrutinib","date":"2025-08-29","year":2025,"use":"To treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroids","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219685s000lbl.pdf","category":"heart-blood","sponsor":"GENZYME CORP","applicationNumber":"NDA219685","dosageForm":"TABLET","route":"ORAL","pharmClass":"Kinase Inhibitor [EPC]","indications":"WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. WAYRILZ is a kinase inhibitor indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. ( 1 )","boxedWarning":false,"setId":"95ffd367-9b0c-4f75-8487-5d8f3c0a5ad0","enrichedAt":"2026-10-11T19:29:19.222Z"},{"slug":"dawnzera","brand":"Dawnzera","generic":"donidalorsen","date":"2025-08-21","year":2025,"use":"To prevent attacks of hereditary angioedema","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219407s000lbl.pdf","category":"rare-genetic","sponsor":"IONIS PHARMS INC","applicationNumber":"NDA219407","dosageForm":"SOLUTION","route":"SUBCUTANEOUS","pharmClass":null,"indications":"DAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is a prekallikrein directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. ( 1 )","boxedWarning":false,"setId":"3ff501e0-f75f-07da-e063-6294a90a0cb7","enrichedAt":"2026-10-11T19:29:19.365Z"},{"slug":"brinsupri","brand":"Brinsupri","generic":"brensocatib","date":"2025-08-12","year":2025,"use":"To treat non-cystic fibrosis bronchiectasis","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217673s000lbl.pdf","category":"kidney-liver-lung","sponsor":"INSMED INC","applicationNumber":"NDA217673","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. ( 1 )","boxedWarning":false,"setId":"b56986ae-e7db-421e-b622-a7f41e321f3d","enrichedAt":"2026-10-11T19:29:19.576Z"},{"slug":"hernexeos","brand":"Hernexeos","generic":"zongertinib","date":"2025-08-08","year":2025,"use":"To treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy","fdaLink":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219042s000lbl.pdf","category":"cancer","sponsor":"BOEHRINGER INGELHEIM","applicationNumber":"NDA219042","dosageForm":"TABLET","route":"ORAL","pharmClass":"Kinase Inhibitor [EPC]","indications":"HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non","boxedWarning":false,"setId":"d3fabf12-354e-4e5c-b5de-20fdb579b783","enrichedAt":"2026-10-11T19:29:19.732Z"},{"slug":"modeyso","brand":"Modeyso","generic":"dordaviprone","date":"2025-08-06","year":2025,"use":"To treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219876s000lbl.pdf","category":"cancer","sponsor":"CHIMERIX","applicationNumber":"NDA219876","dosageForm":"CAPSULE","route":"ORAL","pharmClass":"Protease Activator [EPC]","indications":"MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior ","boxedWarning":false,"setId":"ad45b43e-fdef-47ad-9c34-055b41bdc576","enrichedAt":"2026-10-11T19:29:19.883Z"},{"slug":"vizz","brand":"Vizz","generic":"aceclidine","date":"2025-07-31","year":2025,"use":"To treat presbyopia","fdaLink":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218585s000lbl.pdf","category":"eye","sponsor":"LENZ THERAP","applicationNumber":"NDA218585","dosageForm":"SOLUTION/DROPS","route":"OPHTHALMIC","pharmClass":null,"indications":"VIZZ is indicated for the treatment of presbyopia in adults. VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults ( 1 ).","boxedWarning":false,"setId":"7aed8024-ad30-44d6-8f3b-63338ad3ce52","enrichedAt":"2026-10-11T19:29:20.028Z"},{"slug":"sephience","brand":"Sephience","generic":"sepiapterin","date":"2025-07-28","year":2025,"use":"To treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted diet","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219666s000lbl.pdf","category":"rare-genetic","sponsor":"PTC THERAP","applicationNumber":"NDA219666","dosageForm":"POWDER","route":"ORAL","pharmClass":null,"indications":"SEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)-restricted diet. SEPHIENCE is a phenylalanine hydroxylase (PAH) activator indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). SEPHIENCE is to be used in conjunction with a phenylalanine (Phe)- restricted diet. ( 1 )","boxedWarning":false,"setId":"32ac719c-49f0-4105-9c46-18c19583a5c2","enrichedAt":"2026-10-11T19:29:20.173Z"},{"slug":"anzupgo","brand":"Anzupgo","generic":"delgocitinib","date":"2025-07-23","year":2025,"use":"To treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate response","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219155s000lbl.pdf","category":"immunology","sponsor":"LEO PHARMA AS","applicationNumber":"NDA219155","dosageForm":"CREAM","route":"TOPICAL","pharmClass":"Janus Kinase Inhibitor [EPC]","indications":"ANZUPGO is indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. Limitations of Use Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. ANZUPGO is a Janus kinase (JAK) inhibitor indicated for the topical treatment of moderate to severe chronic hand eczema (CHE) in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable. ( 1 ) Limitations of Use: Use of ANZUPGO in combination with other JAK inhibitors or potent immunosuppressants is not recommended. ( 1 )","boxedWarning":false,"setId":"a59bf36e-6f04-4b47-b385-8040c95f040c","enrichedAt":"2026-10-11T19:29:20.322Z"},{"slug":"ekterly","brand":"Ekterly","generic":"sebetralstat","date":"2025-07-03","year":2025,"use":"To treat acute attacks of hereditary angioedema","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219301s000lbl.pdf","category":"rare-genetic","sponsor":"KALVISTA","applicationNumber":"NDA219301","dosageForm":"TABLET","route":"ORAL","pharmClass":"Plasma Kallikrein Inhibitor [EPC]","indications":"EKTERLY® is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY ® is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )","boxedWarning":false,"setId":"1d145e2f-8e7e-2e90-e063-6294a90a4449","enrichedAt":"2026-10-11T19:29:20.469Z"},{"slug":"lynozyfic","brand":"Lynozyfic","generic":"linvoseltamab-gcpt","date":"2025-07-02","year":2025,"use":"To treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibody","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761400s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:29:20.740Z"},{"slug":"zegfrovy","brand":"Zegfrovy","generic":"sunvozertinib","date":"2025-07-02","year":2025,"use":"To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219839s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:29:20.604Z"},{"slug":"andembry","brand":"Andembry","generic":"garadacimab-gxii","date":"2025-06-16","year":2025,"use":"To prevent attacks of hereditary angioedema","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761367s000lbl.pdf","category":"rare-genetic","sponsor":"CSL BEHRING LLC","applicationNumber":"BLA761367","dosageForm":"INJECTABLE","route":"SUBCUTANEOUS","pharmClass":null,"indications":"ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )","boxedWarning":false,"setId":"07b0b671-db81-49f0-a402-0c0219db7fa2","enrichedAt":"2026-10-11T19:29:20.937Z"},{"slug":"ibtrozi","brand":"Ibtrozi","generic":"taletrectinib","date":"2025-06-11","year":2025,"use":"To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219713s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:29:21.076Z"},{"slug":"enflonsia","brand":"Enflonsia","generic":"clesrovimab-cfor","date":"2025-06-09","year":2025,"use":"To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761432s000lbledt.pdf","category":"infectious-disease","sponsor":"MERCK SHARP DOHME","applicationNumber":"BLA761432","dosageForm":"INJECTION","route":"SOLUTION","pharmClass":"Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]","indications":"ENFLONSIA is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. ENFLONSIA is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. ( 1 )","boxedWarning":false,"setId":"c9004a92-40e8-4cdb-b22d-d07929f8fc3b","enrichedAt":"2026-10-11T19:29:21.229Z"},{"slug":"tryptyr","brand":"Tryptyr","generic":"acoltremon","date":"2025-05-28","year":2025,"use":"To treat the signs and symptoms of dry eye disease","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217370s000lbl.pdf","category":"eye","sponsor":"ALCON LABS INC","applicationNumber":"NDA217370","dosageForm":"SOLUTION/DROPS","route":"OPHTHALMIC","pharmClass":"TRPM8 Thermoreceptor Agonist [EPC]","indications":"TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )","boxedWarning":false,"setId":"2b7715a1-035c-4002-b582-5238efee5d58","enrichedAt":"2026-10-11T19:29:21.371Z"},{"slug":"emrelis","brand":"Emrelis","generic":"telisotuzumab vedotin-tllv","date":"2025-05-14","year":2025,"use":"To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761384s000lbl.pdf","category":"cancer","sponsor":"ABBVIE INC","applicationNumber":"BLA761384","dosageForm":"VIAL","route":"SINGLE-DOSE","pharmClass":null,"indications":"EMRELIS is indicated for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test [see Dosage and Administration ( 2.1 )] , who have received a prior systemic therapy . This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR) [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). EMRELIS is a c-Met-directed antibody and microtubul","boxedWarning":false,"setId":"bc04f980-3957-4e35-ab81-8ec2ffe87215","enrichedAt":"2026-10-11T19:29:21.515Z"},{"slug":"avmapki-fakzynja-co-pack","brand":"Avmapki Fakzynja Co-Pack","generic":"avutometinib and defactinib","date":"2025-05-08","year":2025,"use":"To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219616s000lbl.pdf","category":"cancer","sponsor":"VERASTEM INC","applicationNumber":"NDA219616","dosageForm":"CAPSULE, TABLET","route":"ORAL","pharmClass":null,"indications":"AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior sy","boxedWarning":false,"setId":"65889527-1406-45df-8a85-e2690dcf427d","enrichedAt":"2026-10-11T19:29:21.662Z"},{"slug":"imaavy","brand":"Imaavy","generic":"nipocalimab-aahu","date":"2025-04-29","year":2025,"use":"To treat generalized myasthenia gravis","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761430s000lbl.pdf","category":"neurology-psychiatry","sponsor":"JANSSEN BIOTECH","applicationNumber":"BLA761430","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":null,"indications":"IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of: generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. ( 1.1 ) warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. ( 1.2 ) 1.1 Generalized Myasthenia Gravis (gMG) IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kina","boxedWarning":false,"setId":"8886274c-f2b2-48af-85c1-2f90bfe304b8","enrichedAt":"2026-10-11T19:29:21.856Z"},{"slug":"penpulimab-kcqx","brand":"penpulimab-kcqx","generic":"penpulimab-kcqx","date":"2025-04-23","year":2025,"use":"In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761258Orig1s000correctedlbl.pdf","category":"cancer","sponsor":"AKESO BIOPHARMA","applicationNumber":"BLA761258","dosageForm":"INJECTABLE","route":"INTRAVENOUS","pharmClass":null,"indications":"Penpulimab-kcqx is a programmed death receptor-1 (PD-1)-blocking antibody indicated: in combination with either cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. ( 1.2 ) 1.1 First-line Treatment of Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma Penpulimab-kcqx, in combination with either cisplatin or carboplatin and gemcitabine, is indicated for the first-line treatment","boxedWarning":false,"setId":"830004e8-31af-4cc6-ab16-e870cab1c5ca","enrichedAt":"2026-10-11T19:29:22.010Z"},{"slug":"vanrafia","brand":"Vanrafia","generic":"atrasentan","date":"2025-04-02","year":2025,"use":"To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219208s000lbl.pdf","category":"kidney-liver-lung","sponsor":"NOVARTIS","applicationNumber":"NDA219208","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction of proteinuria [see Clinical Studies (14.1)] . It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VANRAFIA is an endothelin receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy","boxedWarning":true,"setId":"9a7e7f85-bfd0-44a0-beda-3bcfa8215c64","enrichedAt":"2026-10-11T19:29:22.185Z"},{"slug":"qfitlia","brand":"Qfitlia","generic":"fitusiran","date":"2025-03-28","year":2025,"use":"To prevent or reduce the frequency of bleeding episodes in hemophilia A or B","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219019s000lbl.pdf","category":"heart-blood","sponsor":"GENZYME CORP","applicationNumber":"NDA219019","dosageForm":"SOLUTION","route":"SUBCUTANEOUS","pharmClass":"Antithrombin-directed RNA Interaction [EPC]","indications":"QFITLIA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. QFITLIA is an antithrombin-directed small interfering ribonucleic acid indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors. ( 1 )","boxedWarning":true,"setId":"6dd2f8ac-6f90-4cbf-b197-97d74964135c","enrichedAt":"2026-10-11T19:29:22.349Z"},{"slug":"blujepa","brand":"Blujepa","generic":"gepotidacin","date":"2025-03-25","year":2025,"use":"To treat uncomplicated urinary tract infections","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf","category":"infectious-disease","sponsor":"GLAXOSMITHKLINE","applicationNumber":"NDA218230","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. ( 1.2 , 6.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug","boxedWarning":false,"setId":"80b57cfe-7819-4d95-a57d-014af42f118d","enrichedAt":"2026-10-12T07:11:33.826Z"},{"slug":"romvimza","brand":"Romvimza","generic":"vimseltinib","date":"2025-02-14","year":2025,"use":"To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219304s000lbl.pdf","category":"cancer","sponsor":"DECIPHERA PHARMS","applicationNumber":"NDA219304","dosageForm":"CAPSULE","route":"ORAL","pharmClass":"Kinase Inhibitor [EPC]","indications":"ROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ( 1 )","boxedWarning":false,"setId":"f73c7a62-9601-4df0-810f-100f515d79ea","enrichedAt":"2026-10-12T07:11:34.277Z"},{"slug":"gomekli","brand":"Gomekli","generic":"mirdametinib","date":"2025-02-11","year":2025,"use":"To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219379Orig1s000lbl.pdf","category":"other","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-12T07:11:34.548Z"},{"slug":"journavx","brand":"Journavx","generic":"suzetrigine","date":"2025-01-30","year":2025,"use":"To treat moderate to severe acute pain","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219209s000lbl.pdf","category":"pain-anesthesia","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":"Sodium Channel Blocker [EPC]","indications":"JOURNAVX is indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. JOURNAVX is a sodium channel blocker indicated for the treatment of moderate to severe acute pain, including postoperative pain, in adults. ( 1 )","boxedWarning":false,"setId":"d229cf71-96ec-4206-960b-d56fafc250ac","enrichedAt":"2026-10-12T07:11:34.905Z"},{"slug":"grafapex","brand":"Grafapex","generic":"treosulfan","date":"2025-01-21","year":2025,"use":"For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214759s000lbl.pdf","category":"cancer","sponsor":"MEDEXUS","applicationNumber":"NDA214759","dosageForm":"POWDER","route":"INTRAVENOUS","pharmClass":null,"indications":"GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). ( 1.1 ). Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS). ( 1.2 ). 1.1 Acute Myeloid Leukemia GRAFAPEX is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age an","boxedWarning":true,"setId":"2d06b03c-17aa-0492-e063-6294a90abd8f","enrichedAt":"2026-10-12T07:11:35.224Z"},{"slug":"datroway","brand":"Datroway","generic":"datopotamab deruxtecan-dlnk","date":"2025-01-17","year":2025,"use":"To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761394s000lbl.pdf","category":"cancer","sponsor":"DAIICHI SANKYO INC","applicationNumber":"BLA761394","dosageForm":"INJECTABLE","route":"IV (INFUSION)","pharmClass":null,"indications":"DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. ( 1.1 ) This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) wh","boxedWarning":false,"setId":"2950227c-6230-4ca4-a135-46e44d9424a0","enrichedAt":"2026-10-12T07:11:35.683Z"},{"slug":"alyftrek","brand":"Alyftrek","generic":"vanzacaftor, tezacaftor, and deutivacaftor","date":"2024-12-20","year":2024,"use":"For the treatment of cystic fibrosis (CF) in patients 6 years of age and older","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218730s000lbl.pdf","category":"kidney-liver-lung","sponsor":"VERTEX PHARMS INC","applicationNumber":"NDA218730","dosageForm":"TABLET","route":"ORAL","pharmClass":"Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]","indications":"ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 5 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ALYFTREK is a combinat","boxedWarning":true,"setId":"7e635909-c6fd-4f0d-ae77-cdff03653a20","enrichedAt":"2026-10-11T19:28:34.942Z"},{"slug":"alhemo","brand":"Alhemo","generic":"concizumab-mtci","date":"2024-12-20","year":2024,"use":"For routine prophylaxis to prevent bleeding episodes in hemophilia A and B","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761315s000lbl.pdf","category":"heart-blood","sponsor":"NOVO NORDISK INC","applicationNumber":"BLA761315","dosageForm":"Injectable","route":"Subcutaneous","pharmClass":"Tissue Factor Pathway Inhibitor Antagonist [EPC]","indications":"Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors • hemophilia B (congenital factor IX deficiency) with or without FIX inh","boxedWarning":false,"setId":"156f6404-1f6f-417f-bcf8-f07a27a82cc1","enrichedAt":"2026-10-11T19:28:34.532Z"},{"slug":"tryngolza","brand":"Tryngolza","generic":"olezarsen","date":"2024-12-19","year":2024,"use":"To treat familial chylomicronemia syndrome","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218614s000lbl.pdf","category":"weight-loss-diabetes","sponsor":"IONIS PHARMS INC","applicationNumber":"NDA218614","dosageForm":"SOLUTION","route":"SUBCUTANEOUS","pharmClass":null,"indications":"TRYNGOLZA ® is indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). TRYNGOLZA is an apolipoprotein C-III (apoC-III)-directed antisense oligonucleotide (ASO) indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). ( 1 ) To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). ( 1 )","boxedWarning":false,"setId":"0f51aa8e-8475-8cf9-e063-6394a90a6848","enrichedAt":"2026-10-11T19:28:35.425Z"},{"slug":"ensacove","brand":"Ensacove","generic":"ensartinib","date":"2024-12-18","year":2024,"use":"To treat non-small cell lung cancer","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218171s000lbl.pdf","category":"cancer","sponsor":"XCOVERY","applicationNumber":"NDA218171","dosageForm":"CAPSULE","route":"ORAL","pharmClass":null,"indications":"ENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] who have not previously received an ALK-inhibitor. ENSACOVE is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test who have not previously received an ALK-inhibitor. ( 1 , 2.1 )","boxedWarning":false,"setId":"1e1b2f79-678a-472a-b924-66909c8a4b2e","enrichedAt":"2026-10-11T19:28:35.713Z"},{"slug":"unloxcyt","brand":"Unloxcyt","generic":"cosibelimab-ipdl","date":"2024-12-13","year":2024,"use":"To treat cutaneous squamous cell carcinoma","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761297s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:36.037Z"},{"slug":"crenessity","brand":"Crenessity","generic":"crinecerfont","date":"2024-12-13","year":2024,"use":"To treat classic congenital adrenal hyperplasia","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218808s000,218820s000lbl.pdf","category":"womens-health","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:35.873Z"},{"slug":"bizengri","brand":"Bizengri","generic":"zenocutuzumab-zbco","date":"2024-12-04","year":2024,"use":"To treat non-small cell lung cancer and pancreatic adenocarcinoma","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761352s001lbl.pdf","category":"cancer","sponsor":"MERUS N.V.","applicationNumber":"BLA761352","dosageForm":"INJECTION","route":"SOLUTION","pharmClass":null,"indications":"BIZENGRI® is a bispecific HER2- and HER3-directed antibody indicated for the treatment of: Adults with advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.1 ) Adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.* ( 1.2 ) Adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy. ( 1.3 ) *This indication is approved under ","boxedWarning":true,"setId":"203daea4-fc87-40a4-a92f-ba2351b16de1","enrichedAt":"2026-10-11T19:28:36.280Z"},{"slug":"iomervu","brand":"Iomervu","generic":"iomeprol","date":"2024-11-27","year":2024,"use":"For use as a radiographic contrast agent","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216017s000,216017s000lbl.pdf","category":"diagnostic-imaging","sponsor":"BRACCO","applicationNumber":"NDA216016","dosageForm":"SOLUTION","route":"INTRA-ARTERIAL","pharmClass":"Radiographic Contrast Agent [EPC]","indications":"IOMERVU is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients Visceral and peripheral arteriography and aortography, including IA-DSA, in adults and pediatric patients Coronary arteriography and cardiac ventriculography in adults Radiographic evaluation of cardiac chambers and related arteries in pediatric patients Intravenous Procedures † ( 1.2 ) Computed tomography (CT) of the head and body in adults and pediatric patients CT angiography of intracranial, visceral, and lower extremity arteries in adults and pediatric patients Coronary CT an","boxedWarning":true,"setId":"cb2e0e00-7c93-0fb4-89a5-861641662a5a","enrichedAt":"2026-10-11T19:28:36.533Z"},{"slug":"attruby","brand":"Attruby","generic":"acoramidis","date":"2024-11-22","year":2024,"use":"To treat cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216540s000lbl.pdf","category":"heart-blood","sponsor":"BRIDGEBIO PHARMA","applicationNumber":"NDA216540","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"ATTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. ATTRUBY is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization. ( 1 , 2.1 )","boxedWarning":false,"setId":"913552ef-875d-4cb7-bf05-a7d20a394c38","enrichedAt":"2026-10-11T19:28:36.859Z"},{"slug":"rapiblyk","brand":"Rapiblyk","generic":"landiolol","date":"2024-11-22","year":2024,"use":"To treat supraventricular tachycardia","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217202s000lbl.pdf","category":"heart-blood","sponsor":"AOP HLTH US","applicationNumber":"NDA217202","dosageForm":"POWDER","route":"INTRAVENOUS","pharmClass":null,"indications":"RAPIBLYK is indicated for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter, and pediatric patients with supraventricular tachycardia. RAPIBLYK is a beta adrenergic blocker indicated for the short-term reduction of ventricular rate in: adults with supraventricular tachycardia including atrial fibrillation and atrial flutter ( 1 ), and pediatric patients with supraventricular tachycardia.( 1 )","boxedWarning":false,"setId":"27e7f20f-78a4-f1a9-e063-6394a90ae465","enrichedAt":"2026-10-11T19:28:36.697Z"},{"slug":"ziihera","brand":"Ziihera","generic":"zanidatamab-hrii","date":"2024-11-20","year":2024,"use":"To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761416s000lbl.pdf","category":"cancer","sponsor":"JAZZ PHARMS","applicationNumber":"BLA761416","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":"Bispecific HER2-directed Antibody [EPC]","indications":"ZIIHERA is a bispecific HER2-directed antibody indicated for: Gastroesophageal Adenocarcinoma (GEA) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test. ( 1.1 ) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, as first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma,","boxedWarning":true,"setId":"ae5d9425-fae5-4541-a158-150998343348","enrichedAt":"2026-10-11T19:28:37.027Z"},{"slug":"revuforj","brand":"Revuforj","generic":"revumenib","date":"2024-11-15","year":2024,"use":"To treat relapsed or refractory acute leukemia","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218944s000lbl.pdf","category":"cancer","sponsor":"SYNDAX","applicationNumber":"NDA218944","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-","boxedWarning":true,"setId":"6eb3cdbc-0e74-477d-82d6-3bb172d3f63f","enrichedAt":"2026-10-11T19:28:37.194Z"},{"slug":"orlynvah","brand":"Orlynvah","generic":"sulopenem etzadroxil, probenecid","date":"2024-10-25","year":2024,"use":"To treat uncomplicated urinary tract infections (uUTI)","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213972s000lbl.pdf","category":"infectious-disease","sponsor":"ITERUM THERAP","applicationNumber":"NDA213972","dosageForm":"TABLET","route":"ORAL","pharmClass":null,"indications":"ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. ( 1.1 ) Limitations of Use ORLYNVAH is not indicated for the treatment of: Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI. ( 1.1 , 14.2 ) Complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous anti","boxedWarning":false,"setId":"24c451c0-4cfb-37f3-e063-6394a90a895e","enrichedAt":"2026-10-11T19:28:37.364Z"},{"slug":"vyloy","brand":"Vyloy","generic":"zolbetuximab-clzb","date":"2024-10-18","year":2024,"use":"To treat gastric or gastroesophageal junction adenocarcinoma","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761365s000lbl.pdf","category":"cancer","sponsor":"ASTELLAS","applicationNumber":"BLA761365","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":"Claudin 18.2-directed Cytolytic Antibody [EPC]","indications":"VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration ( 2.1 ) and Clinical Studies ( 14 )]. VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal ","boxedWarning":false,"setId":"e7695a21-abb6-47ac-93f8-0ece5a9c4409","enrichedAt":"2026-10-11T19:28:37.528Z"},{"slug":"hympavzi","brand":"Hympavzi","generic":"marstacimab-hncq","date":"2024-10-11","year":2024,"use":"To prevent or reduce bleeding episodes related to hemophilia A or B","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761369s000lbl.pdf","category":"heart-blood","sponsor":"PFIZER INC","applicationNumber":"BLA761369","dosageForm":"INJECTABLE","route":"SUBCUTANEOUS","pharmClass":null,"indications":"HYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or • hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. HYMPAVZI is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with: • hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or • hemophilia B (congenital factor IX defi","boxedWarning":false,"setId":"a2cc631e-13a6-40c2-acf9-065ccedfb90a","enrichedAt":"2026-10-11T19:28:37.704Z"},{"slug":"itovebi","brand":"Itovebi","generic":"inavolisib","date":"2024-10-10","year":2024,"use":"To treat locally advanced or metastatic breast cancer","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219249s001lbl.pdf","category":"cancer","sponsor":"GENENTECH INC","applicationNumber":"NDA219249","dosageForm":"TABLET","route":"ORAL","pharmClass":"Kinase Inhibitor [EPC]","indications":"ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy [see Clinical Studies (14.1) ] . ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic b","boxedWarning":false,"setId":"5de59f5b-e5db-410f-b692-658686ef4107","enrichedAt":"2026-10-11T19:28:37.883Z"},{"slug":"flyrcado","brand":"Flyrcado","generic":"flurpiridaz F 18","date":"2024-09-27","year":2024,"use":"A radioactive diagnostic drug to evaluate for myocardial ischemia and infarction","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215168s000lbl.pdf","category":"heart-blood","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:38.047Z"},{"slug":"cobenfy","brand":"Cobenfy","generic":"xanomeline and trospium chloride","date":"2024-09-26","year":2024,"use":"To treat schizophrenia","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216158s000lbl.pdf","category":"other","sponsor":"BRISTOL-MYERS","applicationNumber":"NDA216158","dosageForm":"CAPSULE","route":"ORAL","pharmClass":"Cholinergic Muscarinic Agonist [EPC]","indications":"COBENFY is indicated for the treatment of schizophrenia in adults. COBENFY is a combination of xanomeline, a muscarinic agonist, and trospium chloride, a muscarinic antagonist, indicated for the treatment of schizophrenia in adults. ( 1 )","boxedWarning":false,"setId":"8f0e73bf-6025-44f6-ab64-0983322de0df","enrichedAt":"2026-10-11T19:28:38.549Z"},{"slug":"aqneursa","brand":"Aqneursa","generic":"levacetylleucine","date":"2024-09-24","year":2024,"use":"To treat Niemann-Pick disease type C","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219132s000lbl.pdf","category":"rare-genetic","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:38.840Z"},{"slug":"miplyffa","brand":"Miplyffa","generic":"arimoclomol","date":"2024-09-20","year":2024,"use":"To treat Niemann-Pick disease type C","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214927s000lbl.pdf","category":"rare-genetic","sponsor":"ZEVRA DENMARK","applicationNumber":"NDA214927","dosageForm":"CAPSULE","route":"ORAL","pharmClass":null,"indications":"MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. ( 1 )","boxedWarning":false,"setId":"5feffc0e-453d-47fa-91dd-38d4952309bc","enrichedAt":"2026-10-11T19:28:39.007Z"},{"slug":"ebglyss","brand":"Ebglyss","generic":"lebrikizumab-lbkz","date":"2024-09-13","year":2024,"use":"To treat moderate-to-severe atopic dermatitis","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761306Orig1s000correctedlbl.pdf","category":"immunology","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:39.164Z"},{"slug":"lazcluze","brand":"Lazcluze","generic":"lazertinib","date":"2024-08-19","year":2024,"use":"To treat non-small cell lung cancer","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbl.pdf","category":"cancer","sponsor":"JANSSEN BIOTECH","applicationNumber":"NDA219008","dosageForm":"TABLET","route":"ORAL","pharmClass":"Kinase Inhibitor [EPC]","indications":"LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. ( 1 )","boxedWarning":false,"setId":"c417f9ee-2027-4ed5-92ad-3c19266de16c","enrichedAt":"2026-10-11T19:28:39.331Z"},{"slug":"livdelzi","brand":"Livdelzi","generic":"seladelpar","date":"2024-08-14","year":2024,"use":"To treat primary biliary cholangitis (PBC)","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf","category":"kidney-liver-lung","sponsor":"GILEAD SCIENCES INC","applicationNumber":"NDA217899","dosageForm":"CAPSULE","route":"ORAL","pharmClass":null,"indications":"LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP) [see Clinical Studies (14) ] . Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for th","boxedWarning":false,"setId":"89f79d98-135c-40b2-a585-6996c04e599c","enrichedAt":"2026-10-11T19:28:39.658Z"},{"slug":"niktimvo","brand":"Niktimvo","generic":"axatilimab-csfr","date":"2024-08-14","year":2024,"use":"To treat chronic graft-versus-host disease (cGVHD)","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761411s000lbl.pdf","category":"immunology","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:39.492Z"},{"slug":"nemluvio","brand":"Nemluvio","generic":"nemolizumab-ilto","date":"2024-08-12","year":2024,"use":"To treat prurigo nodularis","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761390s000lbl.pdf","category":"immunology","sponsor":"GALDERMA LABS LP","applicationNumber":"BLA761390","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":"Interleukin-31 Receptor alpha Antagonist [EPC]","indications":"NEMLUVIO is an interleukin-31 receptor antagonist indicated for: Prurigo Nodularis The treatment of adults with prurigo nodularis. ( 1.1 ) Atopic Dermatitis The treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. ( 1.2 ) 1.1 Prurigo Nodularis NEMLUVIO is indicated for the treatment of adults with prurigo nodularis. 1.2 Atopic Dermatitis NEMLUVIO is indicated for the treatment of adults and pediatric patients 12 years of age and older with moderate-to-severe atopic dermatitis in c","boxedWarning":false,"setId":"e9229ef1-ac60-4c24-afb6-009d3c781687","enrichedAt":"2026-10-11T19:28:39.829Z"},{"slug":"yorvipath","brand":"Yorvipath","generic":"palopegteriparatide","date":"2024-08-09","year":2024,"use":"To treat hypoparathyroidism","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216490s000lbl.pdf","category":"womens-health","sponsor":"ASCENDIS PHARMA BONE","applicationNumber":"NDA216490","dosageForm":"SOLUTION","route":"SUBCUTANEOUS","pharmClass":null,"indications":"YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. ( 1 ) Limitations of Use : Not studied for acute post-surgical hypoparathyroidism. ( 1 ) Titration scheme only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D treatment. ( 1 ) Limitations of Use YORVIPATH was not studied for acute post-surgical hypoparathyroidism. YORVIPATH's titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vita","boxedWarning":false,"setId":"a1fa23fd-c434-443e-9a17-5750578c8602","enrichedAt":"2026-10-11T19:28:40.002Z"},{"slug":"voranigo","brand":"Voranigo","generic":"vorasidenib","date":"2024-08-06","year":2024,"use":"To treat Grade 2 astrocytoma or oligodendroglioma","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218784s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:40.166Z"},{"slug":"leqselvi","brand":"Leqselvi","generic":"deuruxolitinib","date":"2024-07-25","year":2024,"use":"To treat severe alopecia areata","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217900Orig1s000correctedlbl.pdf","category":"immunology","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:40.331Z"},{"slug":"kisunla","brand":"Kisunla","generic":"donanemab-azbt","date":"2024-07-02","year":2024,"use":"To treat Alzheimer’s disease","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf","category":"neurology-psychiatry","sponsor":"ELI LILLY CO","applicationNumber":"BLA761248","dosageForm":"INJECTABLE","route":"INJECTION","pharmClass":null,"indications":"KISUNLA TM is indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. KISUNLA is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with KISUNLA should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. ( 1 )","boxedWarning":true,"setId":"190352d4-ef62-4679-b4fa-e846e2766afa","enrichedAt":"2026-10-11T19:28:40.509Z"},{"slug":"ohtuvayre","brand":"Ohtuvayre","generic":"ensifentrine","date":"2024-06-26","year":2024,"use":"To treat chronic obstructive pulmonary disease","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217389s000lbl.pdf","category":"immunology","sponsor":"MSD","applicationNumber":"NDA217389","dosageForm":"SUSPENSION","route":"INHALATION","pharmClass":"Phosphodiesterase 3 Inhibitor [EPC]","indications":"OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1 )","boxedWarning":false,"setId":"e6433c98-41a0-4f99-8f7f-d0e9db6e3f40","enrichedAt":"2026-10-11T19:28:40.683Z"},{"slug":"piasky","brand":"Piasky","generic":"crovalimab-akkz","date":"2024-06-20","year":2024,"use":"To treat paroxysmal nocturnal hemoglobinuria","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761388s000lbl.pdf","category":"heart-blood","sponsor":"GENENTECH INC","applicationNumber":"BLA761388","dosageForm":"INJECTABLE","route":"INTRAVENOUS","pharmClass":"Complement C5 Inhibitor [EPC]","indications":"PIASKY is indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg. PIASKY is a complement C5 inhibitor indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinuria (PNH) and body weight of at least 40 kg ( 1 )","boxedWarning":true,"setId":"2597efc2-a97b-487c-b500-a67fd282a73b","enrichedAt":"2026-10-11T19:28:40.849Z"},{"slug":"sofdra","brand":"Sofdra","generic":"sofpironium","date":"2024-06-18","year":2024,"use":"To treat primary axillary hyperhidrosis","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf","category":"other","sponsor":"BOTANIX SB","applicationNumber":"NDA217347","dosageForm":"GEL, METERED","route":"TOPICAL","pharmClass":null,"indications":"SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).","boxedWarning":false,"setId":"78f86f4f-658c-468b-bd54-49182ddcc7ac","enrichedAt":"2026-10-11T19:28:41.013Z"},{"slug":"iqirvo","brand":"Iqirvo","generic":"elafibranor","date":"2024-06-10","year":2024,"use":"To treat primary biliary cholangitis in combination with ursodeoxycholic acid","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218860s000lbl.pdf","category":"kidney-liver-lung","sponsor":"IPSEN","applicationNumber":"NDA218860","dosageForm":"TABLET","route":"ORAL","pharmClass":"Peroxisome Proliferator-activated Receptor Agonist [EPC]","indications":"IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP) [see Clinical Studies (14) ] . Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). IQIRVO is a peroxisome proliferator-activated receptor (PPAR) agonist indicated for the treatment ","boxedWarning":false,"setId":"d78aa14f-6ec1-4b1d-a4ae-e48658137a25","enrichedAt":"2026-10-11T19:28:41.178Z"},{"slug":"rytelo","brand":"Rytelo","generic":"imetelstat","date":"2024-06-06","year":2024,"use":"To treat low- to intermediate-1 risk myelodysplastic syndromes","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217779s000lbl.pdf","category":"cancer","sponsor":"GERON","applicationNumber":"NDA217779","dosageForm":"POWDER","route":"INTRAVENOUS","pharmClass":null,"indications":"1. INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). RYTELO is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating age","boxedWarning":false,"setId":"b0fab7ca-e578-43c5-9df6-bdaff4182257","enrichedAt":"2026-10-11T19:28:41.358Z"},{"slug":"imdelltra","brand":"Imdelltra","generic":"tarlatamab-dlle","date":"2024-05-16","year":2024,"use":"To treat extensive stage small cell lung cancer","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:41.515Z"},{"slug":"xolremdi","brand":"Xolremdi","generic":"mavorixafor","date":"2024-04-26","year":2024,"use":"To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis)","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218709s000lbl.pdf","category":"rare-genetic","sponsor":"X4 PHARMS","applicationNumber":"NDA218709","dosageForm":"CAPSULE","route":"ORAL","pharmClass":"CXC Chemokine Receptor 4 Antagonist [EPC]","indications":"XOLREMDI is indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lympocytes. XOLREMDI is a CXC chemokine receptor 4 antagonist indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. ( 1 )","boxedWarning":false,"setId":"7f3a5ee3-ca73-4876-85a0-ed1e108a2237","enrichedAt":"2026-10-11T19:28:41.690Z"},{"slug":"ojemda","brand":"Ojemda","generic":"tovorafenib","date":"2024-04-23","year":2024,"use":"To treat relapsed or refractory pediatric low-grade glioma","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf","category":"cancer","sponsor":"DAY ONE BIOPHARMS","applicationNumber":"NDA218033","dosageForm":"FOR SUSPENSION","route":"ORAL","pharmClass":"Kinase Inhibitor [EPC]","indications":"OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. ( 1 )","boxedWarning":false,"setId":"ea3a9631-3a66-6a7c-e053-2995a90ae2ad","enrichedAt":"2026-10-11T19:28:41.921Z"},{"slug":"anktiva","brand":"Anktiva","generic":"nogapendekin alfa inbakicept-pmln","date":"2024-04-22","year":2024,"use":"To treat bladder cancer","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf","category":"cancer","sponsor":"ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU","applicationNumber":"BLA761336","dosageForm":"SOLUTION","route":"INTRAVESICAL","pharmClass":null,"indications":"ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )","boxedWarning":false,"setId":"eae31db8-3e7a-d9e0-708d-74419d1b50ff","enrichedAt":"2026-10-11T19:28:42.088Z"},{"slug":"lumisight","brand":"Lumisight","generic":"pegulicianine","date":"2024-04-17","year":2024,"use":"To use as an optical imaging agent for the detection of cancerous tissue","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214511s000lbl.pdf","category":"diagnostic-imaging","sponsor":"LUMICELL","applicationNumber":"NDA214511","dosageForm":"POWDER","route":"INTRAVENOUS","pharmClass":null,"indications":"LUMISIGHT is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. LUMISIGHT is an optical imaging agent indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. ( 1 )","boxedWarning":true,"setId":"7160e774-663a-43e4-ba4a-06cc57830e66","enrichedAt":"2026-10-11T19:28:42.258Z"},{"slug":"zevtera","brand":"Zevtera","generic":"ceftobiprole medocaril sodium","date":"2024-04-03","year":2024,"use":"To treat certain bloodstream infections, bacterial skin and associated tissue infections, and community-acquired bacterial pneumonia","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218275s000lbl.pdf","category":"infectious-disease","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-11T19:28:42.424Z"},{"slug":"voydeya","brand":"Voydeya","generic":"danicopan","date":"2024-03-29","year":2024,"use":"To treat extravascular hemolysis with paroxysmal nocturnal hemoglobinuria","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218037s000lbl.pdf","category":"heart-blood","sponsor":"ALEXION PHARMS INC","applicationNumber":"NDA218037","dosageForm":"TABLET","route":"ORAL","pharmClass":"Complement Factor D Inhibitor [EPC]","indications":"VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH). VOYDEYA is a complement factor D inhibitor indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH) ( 1 ). Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab. Limitations of Use VOYDEYA has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab.","boxedWarning":true,"setId":"ab8d1cbd-a28b-4d49-82ab-5c7460719ac7","enrichedAt":"2026-10-12T07:11:35.990Z"},{"slug":"vafseo","brand":"Vafseo","generic":"vadadustat","date":"2024-03-27","year":2024,"use":"To treat anemia due to chronic kidney disease","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215192s000lbl.pdf","category":"heart-blood","sponsor":"AKEBIA","applicationNumber":"NDA215192","dosageForm":"TABLET","route":"ORAL","pharmClass":"Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor [EPC]","indications":"VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia In patients with anemia due to CKD not on dialysis [see Warnings and Precautions ( 5.6 )] . VAFSEO is a hypoxia-inducible factor prolyl hydroxylase (HIF PH) inhibitor indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three mo","boxedWarning":true,"setId":"ac9da724-5a62-4ab6-a89c-376a25f6195b","enrichedAt":"2026-10-12T07:11:36.282Z"},{"slug":"winrevair","brand":"Winrevair","generic":"sotatercept-csrk","date":"2024-03-26","year":2024,"use":"To treat pulmonary arterial hypertension","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363s000lbl.pdf","category":"heart-blood","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-12T07:11:36.554Z"},{"slug":"duvyzat","brand":"Duvyzat","generic":"givinostat","date":"2024-03-21","year":2024,"use":"To treat Duchenne muscular dystrophy in individuals aged 6 years and older","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217865Orig1s000lbl.pdf ","category":"rare-genetic","sponsor":"ITALFARMACO SPA","applicationNumber":"NDA217865","dosageForm":"SUSPENSION","route":"ORAL","pharmClass":"Histone Deacetylase Inhibitor [EPC]","indications":"DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. ( 1 )","boxedWarning":false,"setId":"1a28a3db-7880-4ac2-a2f2-2b4e362aafb6","enrichedAt":"2026-10-12T07:11:36.858Z"},{"slug":"tryvio","brand":"Tryvio","generic":"aprocitentan","date":"2024-03-19","year":2024,"use":"To treat hypertension","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217686s000lbl.pdf","category":"heart-blood","sponsor":"IDORSIA","applicationNumber":"NDA217686","dosageForm":"TABLET","route":"ORAL","pharmClass":"Endothelin Receptor Antagonist [EPC]","indications":"TRYVIO, in combination with other antihypertensive drugs, is indicated for the treatment of hypertension, to lower blood pressure (BP) in adult patients who are not adequately controlled on other drugs. Lowering BP reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating reduction of risk of these events with TRYVIO. Control of high BP should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic ","boxedWarning":true,"setId":"dfe7a2ee-612c-4aba-834a-d68e6b59a0a6","enrichedAt":"2026-10-12T07:11:37.377Z"},{"slug":"rezdiffra","brand":"Rezdiffra","generic":"resmetirom","date":"2024-03-14","year":2024,"use":"To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217785s000lbl.pdf","category":"kidney-liver-lung","sponsor":"MADRIGAL","applicationNumber":"NDA217785","dosageForm":"TABLET","route":"ORAL","pharmClass":"Thyroid Hormone Receptor beta Agonist [EPC]","indications":"REZDIFFRA ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis [see Use in Specific Populations (8.7) , Clinica","boxedWarning":false,"setId":"e67ea09f-a840-439c-86c8-f98585f978b2","enrichedAt":"2026-10-12T07:11:37.659Z"},{"slug":"tevimbra","brand":"Tevimbra","generic":"tislelizumab-jsgr","date":"2024-03-13","year":2024,"use":"To treat unresectable or metastatic esophageal squamous cell carcinoma","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761232Orig1s000lbl.pdf","category":"cancer","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-12T07:11:37.925Z"},{"slug":"letybo","brand":"Letybo","generic":"letibotulinumtoxinA-wlbg","date":"2024-02-29","year":2024,"use":"To temporarily improve the appearance of moderate-to-severe glabellar lines","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761225s000lbl.pdf","category":"other","sponsor":"HUGEL INC","applicationNumber":"BLA761225","dosageForm":"POWDER, FOR SOLUTION","route":null,"pharmClass":"Acetylcholine Release Inhibitor [EPC]","indications":"LETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. LETYBO is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. ( 1 )","boxedWarning":true,"setId":"910e5d0e-4d0b-4de8-8e2d-97879a044181","enrichedAt":"2026-10-12T07:11:38.226Z"},{"slug":"exblifep","brand":"Exblifep","generic":"cefepime, enmetazobactam","date":"2024-02-22","year":2024,"use":"To treat complicated urinary tract infections","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216165s000lbl.pdf","category":"infectious-disease","sponsor":null,"applicationNumber":null,"dosageForm":null,"route":null,"pharmClass":null,"indications":null,"boxedWarning":false,"setId":null,"enrichedAt":"2026-10-12T07:11:38.527Z"},{"slug":"zelsuvmi","brand":"Zelsuvmi","generic":"berdazimer","date":"2024-01-05","year":2024,"use":"To treat molluscum contagiosum","fdaLink":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217424s000lbl.pdf","category":"other","sponsor":"LNHC","applicationNumber":"NDA217424","dosageForm":"GEL","route":"TOPICAL","pharmClass":null,"indications":"ZELSUVMI™ is indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ZELSUVMI™ is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older. ( 1 )","boxedWarning":false,"setId":"76b17622-bdb9-41ea-b962-c2acc0df71f7","enrichedAt":"2026-10-12T07:11:38.788Z"}]}