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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*
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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