If you are looking for the New Drug List for 2025, approved by the FDA. We worked on the consolidation of the list with helpful links and company details.
Novel Drug Approvals for 2025
| No. | Drug Name | Active Ingredient | Approval Date | Company Name | FDA-approved use on approval date* |
| 7 | Qfitlia | Fitusiran | 3/28/2025 | Sanofi | To prevent or reduce the frequency of bleeding episodes in hemophilia A or BPress Release |
| 6 | Blujepa | Gepotidacin | 3/25/2025 | GSK | To treat uncomplicated urinary tract infections |
| 5 | Romvimza | Vimseltinib | 2/14/2025 | Deciphera Pharmaceuticals | 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 | SpringWorks | To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection |
| 3 | Journavx | Suzetrigine | 1/30/2025 | Vertex Pharmaceuticals | To treat moderate to severe acute painPress Release |
| 2 | Grafapex | treosulfan | 1/21/2025 | Medac GmbH | 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 | AstraZeneca | 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 |
Read Also: New Drugs List 2021& 2022 approved by CDSCO
