Drug Name Active Ingredient Approval Date FDA-approved use on approval date
Zycubocopper histidinate1/12/2026To treat Menkes disease
Adqueydifamilast2/12/2026To treat mild to moderate atopic dermatitis
Bysantimilsaperidone2/20/2026To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder
Loargyspegzilarginase-nbln2/23/2026To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction
Yuviwelnavepegritide2/27/2026To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
Lynavoylinerixibat3/17/2026To treat cholestatic pruritus associated with primary biliary cholangitis
Icotydeicotrokinra3/17/2026To 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
Avlayahtividenofusp alfa-eknm3/24/2026To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)
Lifyorlirelacorilant3/25/2026To 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
Awiqliinsulin icodec-abae3/26/2026To improve glycemic control in adults with type 2 diabetes mellitus
Foundayoorforglipron4/1/2026To 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
Idvynsodoravirine and islatravir4/20/2026To 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
Veppanuvepdegestrant5/1/2026To 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
Beqalzisonrotoclax5/13/2026To treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor
Baxfendybaxdrostat5/15/2026To treat hypertension in combination with other antihypertensive drugs
Hepcludexbulevirtide-gmod5/22/2026To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis
Decnupazpivekimab sunirine-pvzy5/27/2026To treat adults with blastic plasmacytoid dendritic cell neoplasm
Zaynichcefepime and zidebactam5/29/2026To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms
Xocovaensitrelvir5/29/2026To use as post-exposure prophylaxis of coronavirus disease 2019 (COVID-19) following contact with an individual who has COVID-19
Cypsedocipepofol5/29/2026To induce general anesthesia in adults undergoing surgery
Ambelvistgadoquatrane6/12/2026To detect and visualize lesions with abnormal vascularity, in conjunction with MRI
Utebzitebipenem pivoxil6/17/2026To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options
Lumvoaveligrotug-vvze6/26/2026To treat thyroid eye disease
Trutaknaatacicept-vymj7/7/2026To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression
Revtorpykgedatolisib7/14/2026In 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
Lipfendraenlicitide decanoate7/15/2026To reduce low-density lipoprotein cholesterol
Jideytrozidesamtinib7/22/2026To treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitor
Lytenavabevacizumab-vikg7/24/2026To treat patients with neovascular (wet) age-related macular degeneration
Simtriyocentanafadine7/24/2026To treat attention-deficit hyperactivity disorder
Orzeyfuloveporexton8/5/2026To treat narcolepsy type 1
Tauklarifyflorquinitau F 188/13/2026To 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
Zenbexusiberdomide8/13/2026To 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
Pasatrugaretosmab-grts8/19/2026To reduce new heterotopic ossification and clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva
Rasonquedaraxonrasib8/26/2026To treat metastatic pancreatic cancer
Lisrayabrepocitinib8/27/2026To treat dermatomyositis in adults
Mimrylorusfertide8/28/2026To treat erythrocytosis in adults with polycythemia vera
Zanvastrozilganersen9/3/2026To treat Alexander disease in pediatric and adult patients
Etcamahcamizestrant9/4/2026To 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
Isembyldapitegromab-mstn9/11/2026To treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are currently receiving an SMN2-targeted treatment
Pixclarafloretyrosine F 189/11/2026To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluations
Onswikinsulin efsitora alfa-gobe9/23/2026To improve glycemic control in adults with type 2 diabetes mellitus, as an adjunct to diet and exercise
Lyrfigtulirafugratinib9/23/2026To adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangement
Juvmotavapadon9/25/2026To treat Parkinson’s disease in adults
Atebriozzilurgisertib9/25/2026To reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva

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*The listed “FDA-approved use” on this page is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, please see the most recently approved Prescribing Information (or Label) available at Drugs@FDA. You can search by drug name, active ingredient, or application number.