Novel Drug Approvals for 2025
Each year, the U.S. Food and Drug Administration (FDA) reviews and approves a select group of new medications known as “novel” drugs—those that have never before been approved or marketed in the United States. These drugs often represent significant scientific and clinical advances, offering new treatment options for diseases with limited or no existing therapies.
Novel drug approvals reflect the ongoing innovation in drug development and the growing understanding of disease biology. They may include new molecular entities (NMEs) or biologics that work through previously unaddressed mechanisms, target rare or challenging conditions, or significantly improve upon the safety, efficacy, or convenience of existing therapies.
This report highlights the novel drugs approved by the FDA in first quarter of 2025, showcasing how cutting-edge science continues to translate into real-world medical solutions that improve—and sometimes save—lives.
List from 1st Jan 2025 – 31st March 2025.
| 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 |
Source: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025
Check FDA Novel Drug Therapy Approvals for 2024 below:
