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 |
| 11 | Avmapki Fakzynja Co-Pack | Avutometinib and Defactinib | 08/05/2025 | Verastem Oncology | To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapy |
| 10 | Imaavy | Nipocalimab-Aahu | 29/04/2025 | Johnson&Johnson | To treat generalized myasthenia gravis |
| 9 | Penpulimab-kcqx | penpulimab-kcqx | 23/04/2025 | Akeso Biopharma Co., Ltd. | 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 | 02/04/2025 | Novartis | To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression |
| 7 | Qfitlia | Fitusiran | 28/3/2025 | 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
FAQ
What is a novel drug FDA?
A novel FDA drug is a New Molecular Entity (NME) with unique mechanisms or clinical benefits for unmet needs, often expedited via pathways like Breakthrough Therapy or Priority Review.Â
What are the changes in the FDA in 2025?
There are some proposals inthe FDA in 2025 that are under consideration like: (i) Enhanced AI/ML Integration, (ii) Diversity in Clinical Trials, (iii) Accelerated Pathways Expansion, and (iv) Supply Chain Resilience.
