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  5. Novel Drug Approvals for 2025
  1. Novel Drug Approvals at FDA

Novel Drug Approvals for 2025

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 2025

No.Drug NameActive IngredientApproval DateFDA-approved use on approval date*
1.Datrowaydatopotamab deruxtecan-dlnk1/17/2025To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

*The listed “FDA-approved use” on this website 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, see the most recent A-approved Prescribing Information (click on the Drug Name).

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