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  1. Novel Drug Approvals at FDA

Novel Drug Approvals for 2026

What are "Novel" Drugs?

"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.

FDA Novel Drug Therapy Approvals for 2026

No.Drug NameActive IngredientApproval DateFDA-approved use on approval date*
15.Baxfendybaxdrostat5/15/2026To treat hypertension in combination with other antihypertensive drugs
14.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
13.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
12.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
11.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
10.Awiqliinsulin icodec-abae3/26/2026To improve glycemic control in adults with type 2 diabetes mellitus
9.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
8.Avlayahtividenofusp alfa-eknm3/24/2026To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)
7.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
6.Lynavoylinerixibat3/17/2026To treat cholestatic pruritus associated with primary biliary cholangitis
5.Yuviwelnavepegritide2/27/2026To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
4.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
3.Bysantimilsaperidone2/20/2026To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder
2.Adqueydifamilast2/12/2026To treat mild to moderate atopic dermatitis
1.Zycubocopper histidinate1/12/2026To treat Menkes disease

*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.

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