Completed BsUFA III Deliverables (Oct 24, 2025 15:27)
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played...

Completed PDUFA VII Deliverables (Oct 24, 2025 15:00)
Since the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, user fees have...

What's New Related to Drugs (Oct 24, 2025 13:07)
Want to know what's new on drugs from FDA? This page provides quick links to the latest...

Oncology (Cancer)/Hematologic Malignancies Approval Notifications (Oct 24, 2025 13:04)
FDA does not issue approval announcements for every approval or drug label update ...

FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation (Oct 24, 2025 13:03)
On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syn...

Novel Drug Approvals for 2025 (Oct 24, 2025 12:58)
Innovative drugs often mean new treatment options for patients and advances in health c...

Generic Drug Facilities, Sites and Organization Lists (Oct 24, 2025 12:31)
Generic Drug Facilities, Sites and Organization Lists