FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

A Massachusetts biotechnology company is laying off nearly 500 employees, more than a third of its total workforce, as it faces pushback from the U.S. Food and Drug Administration on one of its ...

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Two FDA inspectors said the agency needs an additional 100 to 200 experienced investigators to do the work. The job can be grueling. Some inspectors who travel to overseas drug-making factories ...

Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...

The president's proposed budget cuts to the NIH would eventually result in fewer drugs on the market, the U.S. Congressional ...

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...