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What's New: Drugs RSS Feed

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Latest posts

Last updated about 7 hours ago

GDUFA Type II API DMF Payment Receipts Report

about 8 hours ago

GDUFA Type II API DMF Payment Receipts Report

BsUFA III: Fiscal Years 2023-2027

about 8 hours ago

New legislation will be required for FDA to continue collecting biosimilar user...

Notices of Updates

about 8 hours ago

Webpage providing notices of updates to FDA's STIC webpages for antibacterial and...

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

about 11 hours ago

On March 19, 2025, the FDA granted traditional approval to pembrolizumab (Keytruda...

FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

about 12 hours ago

On September 10, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO...

Consumer Updates

about 12 hours ago

Science-based health and safety information you can trust.

Drugs

about 12 hours ago

Consumer articles about over-the-counter and prescription drugs.

Is It Really 'FDA Approved'?

about 13 hours ago

The FDA is responsible for protecting public health by regulating human drugs...

Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned - 09/23/2025

about 14 hours ago

Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23...

Center for Drug Evaluation and Research Organization Chart

about 15 hours ago

Organization chart for the FDA's Center for Drug Evaluation and Research, including...

Artificial Intelligence for Drug Development

3 days ago

FDA recognizes the increased use of AI throughout the drug development process...

External Engagements with FDA for Artificial Intelligence in Drug Development

3 days ago

To discuss the use of AI in connection with a specific development...