FDA Novel Drug Approvals Quarter 4 – 2025: Complete List
In 2025, the FDA approved a wide range of novel drugs addressing cardiovascular disease, cancer, infectious diseases, immunological disorders, and rare conditions. These approvals reflect continued progress in precision medicine, biologics, and first-in-class therapies.
Below is a comprehensive, non-tabulated list of FDA novel drug approvals in 2025, along with their approval dates and approved indications.
FDA Novel Drug Approvals – 2025
- Myqorzo (aficamten) — Approved on December 19, 2025, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
- Exdensur (depemokimab-ulaa) — Approved on December 16, 2025, for the treatment of severe asthma with an eosinophilic phenotype.
- Cardamyst (etripamil) — Approved on December 12, 2025, to treat episodes of paroxysmal supraventricular tachycardia.
- Nuzolvence (zoliflodacin) — Approved on December 12, 2025, for the treatment of uncomplicated urogenital gonorrhea.
- Lerochol (lerodalcibep-liga) — Approved on December 12, 2025, to reduce low-density lipoprotein cholesterol (LDL-C).
- Voyxact — Approved in November 2025 for the prevention of hereditary angioedema attacks.
- Hyrnuo — Approved in November 2025 for the treatment of locally advanced or metastatic ROS1-positive solid tumors.
- Redemplo — Approved in November 2025 to prevent respiratory syncytial virus (RSV) lower respiratory tract disease.
- Komzifti — Approved in November 2025 for the treatment of dry eye disease.
- Kygevvi — Approved in November 2025 to treat KRAS-mutated recurrent low-grade serous ovarian cancer.
- Lynkuet — Approved in October 2025 for the treatment of generalized myasthenia gravis.
- Jascayd — Approved in October 2025 for use in combination with platinum-based chemotherapy for solid tumors.
Key Takeaways from FDA Approvals in 2025
- Increased approvals for rare and orphan diseases
- Strong momentum in precision oncology and targeted therapies
- Continued innovation in infectious disease treatment
- Growth of long-acting biologics for chronic conditions
Conclusion
The FDA’s 2025 novel drug approvals highlight a year of significant therapeutic progress, particularly in areas of high unmet medical need. These approvals are expected to influence clinical practice, research priorities, and pharmaceutical innovation in the coming years.
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Check FDA Novel Drug Therapy Approvals for 2025 | Quarter 2
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