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 Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 7. | Qfitlia | fitusiran | 3/28/2025 | To prevent or reduce the frequency of bleeding episodes in hemophilia A or B Press Release |
| 6. | Blujepa | gepotidacin | 3/25/2025 | To treat uncomplicated urinary tract infections |
| 5. | Romvimza | vimseltinib | 2/14/2025 | To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity |
| 4. | Gomekli | mirdametinib | 2/11/2025 | To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection |
| 3. | Journavx | suzetrigine | 1/30/2025 | To treat moderate to severe acute pain Press Release |
| 2. | Grafapex | treosulfan | 1/21/2025 | For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome |
| 1. | Datroway | datopotamab deruxtecan-dlnk | 1/17/2025 | To 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).
-
Content current as of:
03/31/2025
