While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers ...

With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, ...

The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...

Denali stock up as it begins rolling BLA submission with the FDA for accelerated approval of tividenofusp alfa for the ...

As the FDA wavers from cuts, changes and departures under the second Trump administration, another vital figure of the agency ...

"The ongoing gutting of the FDA is likely to cause American deaths," said the CEO of one medical device developer.

Denali Therapeutics (DNLI) announced that the company’s initiation of a rolling submission of a biologics license application, BLA, for ...

Although HHS says it did not target FDA product reviewers or inspectors, FDA employees who assist with reviews in various capacities were let go, including project managers and staff in administration ...

The sudden departure of Peter Marks, MD, from the FDA has prompted a chorus of criticism and despair from industry leaders and trade organizations.

Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the ...

Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as ...