News

BioSpace1d
After Prasad’s Ouster, Makary Looks for Better Drug, Biologic Alignment at FDA
The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...
FDA’s Reversal on Gene Therapy Helps My Son
Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.
Fierce Pharma1d
Untangling Sarepta’s gene therapy fallout and a growing trust deficit
Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...
BioPharma Dive1d
Moderna to lay off 10% of workforce in ‘difficult but necessary step’
In a memo, CEO Stéphane Bancel said the job cuts are needed to align the struggling vaccine maker’s cost structure with the ...
STAT1dOpinion
Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine
It is hard to imagine someone more equipped and more dedicated to vetting treatments than Vinay Prasad,” writes his former ...
The Man Who Was Too MAHA for the Trump Administration
Vinay Prasad was supposed to be the guy who kept Big Pharma in check. Now he’s gone.
The American Journal of Managed Care2d
FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients
Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...
Fierce Pharma2d
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell and gene therapy: analyst
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Trump drove firing of FDA official
The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.
BioWorld2d
In Broadway trial, a hopeful tune for Alzheimer’s prevention
At the 2025 Alzheimer’s Association International Conference, one of the bigger splashes was made by an experimental cardiovascular drug. Newamsterdam Pharma Co. NV presented data showing that its ...
BioSpace2d
New CDER Head Tidmarsh Will Sub In At Biologics Group After Prasad’s Exit
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...
Fierce Healthcare2d
Susan Monarez confirmed as CDC director
Susan Monarez, Ph.D., was confirmed by the Senate Tuesday as director of the Centers for Disease Control and Prevention (CDC) ...