FDA novel drug approvals, 2025
Brand, generic name, approval date and the use the FDA approved it for. No recommendations. Updated 2026-10-12.
Weight loss & diabetesCancerBrain & mental healthInfections & vaccinesHeart & bloodImmune & inflammatoryKidney, liver & lungEyeWomen's & hormonal healthPain & anesthesiaDiagnostic & imaging agentsRare & geneticOther
NereusOther
tradipitant · Vanda Pharms Inc.To treat vomiting associated with motionYartemleaImmune & inflammatory
narsoplimab-wuug · Omeros CorpTo treat hematopoietic stem cell transplant-associated thrombotic microangiopathyMyqorzoHeart & blood
aficamten · CytokineticsTo treat symptomatic obstructive hypertrophic cardiomyopathyExdensurImmune & inflammatory
depemokimab-ulaa · Glaxosmithkline LLCTo treat severe asthma characterized by an eosinophilic phenotype as an Komziftiadd-on maintenance therapyLerocholHeart & blood
lerodalcibep-liga · Lib Therapeutics, Inc..To reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, as an adjunct to diet and exerciseNuzolvenceInfections & vaccines
zoliflodacin · Entasis TherapTo treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeaeCardamystHeart & blood
etripamil · Milestone Pharms UsaTo treat episodes of paroxysmal supraventricular tachycardiaVoyxactKidney, liver & lung
sibeprenlimab-szsi · Otsuka Pharm Co LtdTo reduce proteinuria in primary immunoglobulin A nephropathy in adults at risk for disease progressionHyrnuoCancer
sevabertinibTo 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 therapyRedemploWeight loss & diabetes
plozasiran · ArrowheadTo reduce triglycerides in adults with familial chylomicronemia syndromeKomziftiCancer
ziftomenib · KuraTo treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment optionsKygevviRare & genetic
doxecitine and doxribtimine · Ucb Inc.To treat thymidine kinase 2 deficiency in patients who start to show symptoms when they are 12 years old or youngerLynkuetWomen's & hormonal health
elinzanetant · Bayer HlthcareTo treat moderate-to-severe vasomotor symptoms due to menopauseJascaydKidney, liver & lung
nerandomilast · Boehringer IngelheimTo treat idiopathic pulmonary fibrosisRhapsidoImmune & inflammatory
remibrutinib · NovartisTo treat chronic spontaneous urticaria in adults who remain symptomatic despite H1 antihistamine treatmentInluriyoCancer
imlunestrantTo 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 therapyPalsonifyWomen's & hormonal health
paltusotine · CrineticsTo treat acromegaly in adults who had an inadequate response to surgery and/or for whom surgery is not an optionKeytruda QlexCancer
pembrolizumab and berahyaluronidase alfa-pmph · Merck Sharp DohmeTo treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumabForzinityRare & genetic
elamipretide · Stealth BiotherapsTo improve muscle strength in patients with Barth syndrome weighing at least 30 kgWayrilzHeart & blood
rilzabrutinib · Genzyme CorpTo treat persistent or chronic immune thrombocytopenia that has not sufficiently responded to immunoglobulins, anti-D therapy, or corticosteroidsDawnzeraRare & genetic
donidalorsen · Ionis Pharms Inc.To prevent attacks of hereditary angioedemaBrinsupriKidney, liver & lung
brensocatib · Insmed Inc.To treat non-cystic fibrosis bronchiectasisHernexeosCancer
zongertinib · Boehringer IngelheimTo 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 therapyModeysoCancer
dordaviprone · ChimerixTo treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapyVizzEye
aceclidine · Lenz TherapTo treat presbyopiaSephienceRare & genetic
sepiapterin · Ptc TherapTo treat hyperphenylalaninemia in patients with sepiapterin-responsive phenylketonuria, in conjunction with a phenylalanine-restricted dietAnzupgoImmune & inflammatory
delgocitinib · Leo Pharma AsTo treat moderate-to-severe chronic hand eczema when topical corticosteroids are not advisable or produce an inadequate responseEkterlyRare & genetic
sebetralstat · KalvistaTo treat acute attacks of hereditary angioedemaLynozyficCancer
linvoseltamab-gcptTo 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 antibodyZegfrovyCancer
sunvozertinibTo 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 chemotherapyAndembryRare & genetic
garadacimab-gxii · Csl Behring LLCTo prevent attacks of hereditary angioedemaIbtroziCancer
taletrectinibTo treat locally advanced or metastatic ROS1-positive non-small cell lung cancerEnflonsiaInfections & vaccines
clesrovimab-cfor · Merck Sharp DohmeTo prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV seasonTryptyrEye
acoltremon · Alcon Labs Inc.To treat the signs and symptoms of dry eye diseaseEmrelisCancer
telisotuzumab vedotin-tllv · Abbvie Inc.To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapyAvmapki Fakzynja Co-PackCancer
avutometinib and defactinib · Verastem Inc.To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapyImaavyBrain & mental health
nipocalimab-aahu · Janssen BiotechTo treat generalized myasthenia gravispenpulimab-kcqxCancer
penpulimab-kcqx · Akeso BiopharmaIn 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 therapyVanrafiaKidney, liver & lung
atrasentan · NovartisTo reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progressionQfitliaHeart & blood
fitusiran · Genzyme CorpTo prevent or reduce the frequency of bleeding episodes in hemophilia A or BBlujepaInfections & vaccines
gepotidacin · GlaxosmithklineTo treat uncomplicated urinary tract infectionsRomvimzaCancer
vimseltinib · Deciphera PharmsTo treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidityGomekliOther
mirdametinibTo treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resectionJournavxPain & anesthesia
suzetrigineTo treat moderate to severe acute painGrafapexCancer
treosulfan · MedexusFor use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndromeDatrowayCancer
datopotamab deruxtecan-dlnk · Daiichi Sankyo Inc.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