The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation ...

Parents of boys with Duchenne muscular dystrophy weigh in on drug innovation and medical regulation.

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy ...

In a memo, CEO Stéphane Bancel said the job cuts are needed to align the struggling vaccine maker’s cost structure with the ...

It is hard to imagine someone more equipped and more dedicated to vetting treatments than Vinay Prasad,” writes his former ...

Vinay Prasad was supposed to be the guy who kept Big Pharma in check. Now he’s gone.

But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

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 ...

George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...

Susan Monarez, Ph.D., was confirmed by the Senate Tuesday as director of the Centers for Disease Control and Prevention (CDC) ...

A controversial hematologist-oncologist who joined FDA this spring and quickly became its top regulator has left the ...