# FDA Medication Tracker

> Independent, facts-only list of novel drugs approved by the U.S. FDA, refreshed daily from FDA CDER's novel drug approvals pages and openFDA. Not affiliated with the FDA. No medical advice.

## Key facts
- Novel approvals so far in 2026: 46
- Years covered: 2024–2026
- Latest: Hovilpri (pritelivir), 2026-10-09, To treat adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapies
- Updated: 2026-10-12T07:11:38.881Z

## Pages
- https://fdamedication.com/ latest approvals
- https://fdamedication.com/year/2026 full 2026 list
- https://fdamedication.com/api/approvals.json machine-readable

## 2026 approvals
- 2026-10-09 Hovilpri (pritelivir): To treat adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapies — https://fdamedication.com/drug/hovilpri
- 2026-09-28 Emcitate (tiratricol): To treat peripheral thyrotoxicosis in patients with MCT8 deficiency — https://fdamedication.com/drug/emcitate
- 2026-09-25 Juvmo (tavapadon): To treat Parkinson’s disease in adults — https://fdamedication.com/drug/juvmo
- 2026-09-25 Atebrioz (zilurgisertib): To reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva — https://fdamedication.com/drug/atebrioz
- 2026-09-23 Onswik (insulin efsitora alfa-gobe): To improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise — https://fdamedication.com/drug/onswik
- 2026-09-23 Lyrfigtu (lirafugratinib): To adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangement — https://fdamedication.com/drug/lyrfigtu
- 2026-09-11 Isembyld (apitegromab-mstn): To treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment — https://fdamedication.com/drug/isembyld
- 2026-09-11 Pixclara (floretyrosine F 18): To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluations — https://fdamedication.com/drug/pixclara
- 2026-09-04 Etcamah (camizestrant): 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 — https://fdamedication.com/drug/etcamah
- 2026-09-03 Zanvastro (zilganersen): To treat Alexander disease in pediatric and adult patients — https://fdamedication.com/drug/zanvastro
- 2026-08-28 Mimrylo (rusfertide): To treat erythrocytosis in adults with polycythemia vera — https://fdamedication.com/drug/mimrylo
- 2026-08-27 Lisraya (brepocitinib): To treat dermatomyositis in adults — https://fdamedication.com/drug/lisraya
- 2026-08-26 Rasonque (daraxonrasib): To treat metastatic pancreatic cancer — https://fdamedication.com/drug/rasonque
- 2026-08-19 Pasatru (garetosmab-grts): To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva — https://fdamedication.com/drug/pasatru
- 2026-08-13 Tauklarify (florquinitau F 18): 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 — https://fdamedication.com/drug/tauklarify
- 2026-08-13 Zenbexus (iberdomide): 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 — https://fdamedication.com/drug/zenbexus
- 2026-08-05 Orzeyful (oveporexton): To treat narcolepsy type 1 — https://fdamedication.com/drug/orzeyful
- 2026-07-24 Lytenava (bevacizumab-vikg): To treat patients with neovascular (wet) age-related macular degeneration — https://fdamedication.com/drug/lytenava
- 2026-07-24 Simtriyo (centanafadine): To treat attention-deficit hyperactivity disorder — https://fdamedication.com/drug/simtriyo
- 2026-07-22 Jideytro (zidesamtinib): To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitor — https://fdamedication.com/drug/jideytro
- 2026-07-15 Lipfendra (enlicitide decanoate): To reduce low-density lipoprotein cholesterol — https://fdamedication.com/drug/lipfendra
- 2026-07-14 Revtorpyk (gedatolisib): 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 — https://fdamedication.com/drug/revtorpyk
- 2026-07-07 Trutakna (atacicept-vymj): To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression — https://fdamedication.com/drug/trutakna
- 2026-06-26 Lumvoa (veligrotug-vvze): To treat thyroid eye disease — https://fdamedication.com/drug/lumvoa
- 2026-06-17 Utebzi (tebipenem pivoxil): To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options — https://fdamedication.com/drug/utebzi
- 2026-06-12 Ambelvist (gadoquatrane): To detect and visualize lesions with abnormal vascularity, in conjunction with MRI — https://fdamedication.com/drug/ambelvist
- 2026-05-29 Zaynich (cefepime and zidebactam): To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms — https://fdamedication.com/drug/zaynich
- 2026-05-29 Xocova (ensitrelvir): To use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19 — https://fdamedication.com/drug/xocova
- 2026-05-29 Cypsedo (cipepofol): To induce general anesthesia in adults undergoing surgery — https://fdamedication.com/drug/cypsedo
- 2026-05-27 Decnupaz (pivekimab sunirine-pvzy): To treat adults with blastic plasmacytoid dendritic cell neoplasm — https://fdamedication.com/drug/decnupaz
- 2026-05-22 Hepcludex (bulevirtide-gmod): To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis — https://fdamedication.com/drug/hepcludex
- 2026-05-15 Baxfendy (baxdrostat): To treat hypertension in combination with other antihypertensive drugs — https://fdamedication.com/drug/baxfendy
- 2026-05-13 Beqalzi (sonrotoclax): 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 — https://fdamedication.com/drug/beqalzi
- 2026-05-01 Veppanu (vepdegestrant): 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 — https://fdamedication.com/drug/veppanu
- 2026-04-20 Idvynso (doravirine and islatravir): 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 — https://fdamedication.com/drug/idvynso
- 2026-04-01 Foundayo (orforglipron): 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 — https://fdamedication.com/drug/foundayo
- 2026-03-26 Awiqli (insulin icodec-abae): To improve glycemic control in adults with type 2 diabetes mellitus — https://fdamedication.com/drug/awiqli
- 2026-03-25 Lifyorli (relacorilant): 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 — https://fdamedication.com/drug/lifyorli
- 2026-03-24 Avlayah (tividenofusp alfa-eknm): To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II) — https://fdamedication.com/drug/avlayah
- 2026-03-17 Lynavoy (linerixibat): To treat cholestatic pruritus associated with primary biliary cholangitis — https://fdamedication.com/drug/lynavoy
- 2026-03-17 Icotyde (icotrokinra): 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 — https://fdamedication.com/drug/icotyde
- 2026-02-27 Yuviwel (navepegritide): To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses — https://fdamedication.com/drug/yuviwel
- 2026-02-23 Loargys (pegzilarginase-nbln): To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction — https://fdamedication.com/drug/loargys
- 2026-02-20 Bysanti (milsaperidone): To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder — https://fdamedication.com/drug/bysanti
- 2026-02-12 Adquey (difamilast): To treat mild to moderate atopic dermatitis — https://fdamedication.com/drug/adquey
- 2026-01-12 Zycubo (copper histidinate): To treat Menkes disease — https://fdamedication.com/drug/zycubo