News

Sarepta tells FDA it won’t halt shipments despite patient deaths
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug Administration to halt all shipments of its gene therapy.
Gene therapy maker Sarepta tells FDA it won’t halt shipments despite patient deaths
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments
Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...
MedPage Today1d
A 'Culture Change' Is Needed in Academic Medicine, FDA Commissioner Says
The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The ...
Live coverage: FDA’s Makary talks animal testing phase-out at Hill Nation Summit
Nearly six months into President Trump’s second term, The Hill and NewsNation team up to host the inaugural Hill Nation ...
FDA Commissioner Marty Makary Says The FDA Is 'Now Revising' Saturated Fat Guidelines
During a press conference on Monday, Food and Drug Administration Commissioner Marty Makary spoke about the agency's ...
FDA Commissioner Marty Makary Announces Approval Of New Natural Food Dye
'Fridge cigarette' is Gen Z's new Diet Coke obsession that concerns health experts Job No. 1 done, a ‘Trump original’ hangs out her shingle Landlord seeks to evict Republican congressman over unpaid ...
BioSpace4d
FDA Commissioner Marty Makary Proposes Lowering Industry User Fees
According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...
STAT5dOpinion
The FDA commissioner is a gifted talker — but the job is about more than that
FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the ...
Science-Based Medicine5dOpinion
Go Ahead, Make the Case That Science, Free Speech, and the FDA Are Thriving Under Drs. Marty Makary and Vinay Prasad
Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...