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  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*
5.Romvimzavimseltinib2/14/2025To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity
4.Gomeklimirdametinib2/11/2025To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
3.Journavxsuzetrigine1/30/2025To treat moderate to severe acute pain
Press Release
2.Grafapextreosulfan1/21/2025For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome
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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