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 second 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 April 2025 – 30th June 2025.
| 16. | Andembry | garadacimab-gxii | 6/16/2025 | To prevent attacks of hereditary angioedema |
| 15. | Ibtrozi | taletrectinib | 6/11/2025 | To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer |
| 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 |
Source: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025
Check FDA Novel Drug Therapy Approvals for 2025 Quarter 1 below:
