4 days ago · 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 …

4 days ago · Up to date information on the latest FDA drug approvals. Includes list of most recent approvals, the conditions approved for, and the approval history.

Explore the full list of 2025 FDA drug approvals, 28 new therapies across oncology, rare disease, and more.

Oct 3, 2025 · This list highlights notable medications and vaccines that have been FDA approved so far in 2025. They represent major advancements compared to other available treatment options.

Jun 26, 2025 · Explore the latest FDA-approved novel drugs transforming treatment options for various conditions, enhancing patient care and outcomes in community and specialty pharmacy.

6 days ago · Learn about the clinical trials and research at MSK that led to FDA approvals in 2025, expanding treatment options for a range of different cancers.

Oct 13, 2025 · The third quarter of 2025 delivered a welcome bolus of novel FDA drug approvals, with the 16 approvals in the quarter matching the 16 approvals in total in the first half of the year...

Dec 8, 2025 · Several upcoming PDUFA dates this month could also boost the novel drug approval rate before the year’s out. For now, here’s a look at some of the standout approvals in 2025.

Aug 29, 2025 · Summary Selected drug approvals anticipated in the 12-month period covering the third quarter of 2025 through the second quarter of 2026 are reviewed. The analysis emphasizes drugs …

Jul 6, 2025 · The second quarter of 2025 delivered a wave of impactful FDA approvals across a spectrum of rare and chronic diseases, expanding treatment options and advancing precision medicine.