FDA novel drug approvals, 2026
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
HovilpriInfections & vaccines
pritelivirTo treat adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapiesEmcitateRare & genetic
tiratricolTo treat peripheral thyrotoxicosis in patients with MCT8 deficiencyJuvmoBrain & mental health
tavapadonTo treat Parkinson’s disease in adultsAtebriozRare & genetic
zilurgisertibTo reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressivaOnswikWeight loss & diabetes
insulin efsitora alfa-gobeTo improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exerciseLyrfigtuCancer
lirafugratinibTo adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangementIsembyldBrain & mental health
apitegromab-mstnTo treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatmentPixclaraCancer
floretyrosine F 18To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluationsEtcamahCancer
camizestrant · AstrazenecaTo 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 therapyZanvastroBrain & mental health
zilganersenTo treat Alexander disease in pediatric and adult patientsMimryloHeart & blood
rusfertide · Takeda Pharms AmTo treat erythrocytosis in adults with polycythemia veraLisrayaImmune & inflammatory
brepocitinib · Priovant TherapTo treat dermatomyositis in adultsRasonqueCancer
daraxonrasib · Revolution MedicinesTo treat metastatic pancreatic cancerPasatruRare & genetic
garetosmab-grts · Regeneron Pharmaceuticals, Inc.To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressivaTauklarifyBrain & mental health
florquinitau F 18To 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 pathologyZenbexusCancer
iberdomide · Bristol Myers SquibbTo 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 agentOrzeyfulOther
oveporextonTo treat narcolepsy type 1LytenavaEye
bevacizumab-vikgTo treat patients with neovascular (wet) age-related macular degenerationSimtriyoRare & genetic
centanafadineTo treat attention-deficit hyperactivity disorderJideytroCancer
zidesamtinib · NuvalentTo treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitorLipfendraHeart & blood
enlicitide decanoate · MsdTo reduce low-density lipoprotein cholesterolRevtorpykCancer
gedatolisibIn 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 settingTrutaknaKidney, liver & lung
atacicept-vymj · Vera Therapeutics Inc..To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progressionLumvoaEye
veligrotug-vvze · Viridian Therapeutics Inc.To treat thyroid eye diseaseUtebziInfections & vaccines
tebipenem pivoxilTo treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment optionsAmbelvistDiagnostic & imaging agents
gadoquatrane · Bayer HealthcareTo detect and visualize lesions with abnormal vascularity, in conjunction with MRIZaynichInfections & vaccines
cefepime and zidebactam · Wockhardt Bio AgTo treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganismsXocovaInfections & vaccines
ensitrelvir · ShionogiTo use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19CypsedoPain & anesthesia
cipepofolTo induce general anesthesia in adults undergoing surgeryDecnupazCancer
pivekimab sunirine-pvzy · Abbvie Inc.To treat adults with blastic plasmacytoid dendritic cell neoplasmHepcludexInfections & vaccines
bulevirtide-gmod · Gilead Sciences Inc.To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosisBaxfendyHeart & blood
baxdrostatTo treat hypertension in combination with other antihypertensive drugsBeqalziCancer
sonrotoclaxTo treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitorVeppanuCancer
vepdegestrant · Rigel PharmsTo 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 therapyIdvynsoInfections & vaccines
doravirine and islatravir · MsdTo 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 doravirineFoundayoWeight loss & diabetes
orforglipron · Eli Lilly And CoTo 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 activityAwiqliWeight loss & diabetes
insulin icodec-abaeTo improve glycemic control in adults with type 2 diabetes mellitusLifyorliCancer
relacorilant · Corcept TherapTo 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 bevacizumabAvlayahRare & genetic
tividenofusp alfa-eknm · Denali Therapeutics Inc..To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)LynavoyKidney, liver & lung
linerixibat · InterceptTo treat cholestatic pruritus associated with primary biliary cholangitisIcotydeImmune & inflammatory
icotrokinra · Janssen BiotechTo 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 phototherapyYuviwelRare & genetic
navepegritide · AscendisTo increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphysesLoargysRare & genetic
pegzilarginase-nbln · Immedica Pharma AbTo treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restrictionBysantiBrain & mental health
milsaperidone · Vanda Pharms Inc.To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorderAdqueyImmune & inflammatory
difamilast · Acrotech BiopharmaTo treat mild to moderate atopic dermatitisZycuboRare & genetic
copper histidinate · Sentynl Theraps Inc.To treat Menkes disease