FDA prevails over EMA in 2025 novel drug approvals

This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...
MPR

2025 FDA Approvals: A Summary of Novel Drugs and Biologics

Below is a review of novel drug and biological products approved by the Food and Drug Administration (FDA) in 2025. The list includes several groundbreaking therapies that are expected to change the ...
PharmTech

FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use

M4Q (R2) is a globally harmonized framework for structuring quality information in medicinal product registration ...
Medical News Today

What does FDA approval mean? A guide to understand the process

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
The New York Times

Inside the Collapse of the F.D.A.

How the new health secretary, Robert F. Kennedy Jr., is dismantling the agency. Credit...Animation By Aimee Sy Supported by By Jeneen Interlandi Jeneen Interlandi, a domestic correspondent for Opinion ...
STAT

How the first nine drug companies won priority review vouchers from Marty Makary’s FDA

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — Commissioner Marty ...

Rx Inspector: ProPublica’s New Tool Provides Drug Info the FDA Won’t

We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of the factories that made them.