Fierce Pharma

Senate HELP Committee chair pitches proposals for FDA reform

In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce ...
Becker's Hospital Review

FDA unveils pathway for ultra-rare disease therapies

FDA unveils pathway ultra-rare disease therapies to approve gene-editing and RNA treatments when trials are unfeasible for small populations.

Top Republican eyeing FDA overhaul

Sen. Bill Cassidy (R-La.) on Tuesday unveiled his proposal for modernizing the Food and Drug Administration (FDA), calling on ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...
FoodNavigator-USA

FDA allergen threshold guidance could reduce liability for food brands

FDA allergen thresholds offer food brands science-based guidance on managing cross-contact risks and using advisory ...

FDA rolls out new rare-disease drug playbook

Pharma policy watchers were treated Monday to what’s become a regulatory rarity during the second Trump administration — an FDA guidance document requiring notice and comment from the public.
WCVB Channel 5 Boston

FDA greenlights first blood test to help diagnose Alzheimer’s disease in the US

The U.S. Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, making the test the first to get signoff to aid in the early detection of the ...