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 Name | Active Ingredient | Approval Date | FDA-approved use on approval date* |
|---|---|---|---|---|
| 14 | Enflonsia | clesrovimab-cfor | 6/9/2025 | To prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season |
| 13. | Tryptyr | acoltremon | 5/28/2025 | To treat the signs and symptoms of dry eye disease |
| 12. | Emrelis | telisotuzumab vedotin-tllv | 5/14/2025 | To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapy |
| 11. | Avmapki Fakzynja Co-Pack | avutometinib and defactinib | 5/8/2025 | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy |
| 10. | Imaavy | nipocalimab-aahu | 4/29/2025 | To treat generalized myasthenia gravis |
| 9. | penpulimab-kcqx | penpulimab-kcqx | 4/23/2025 | In combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapy |
| 8. | Vanrafia | atrasentan | 4/02/2025 | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression |
| 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, 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.