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

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

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

By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop ...

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

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

HHS faces other legal challenges over its workforce cuts. A class-action lawsuit in the U.S. Court for the District of Columbia claims the department relied on “hopelessly error-ridden” data when it ...

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

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 ...

Sarepta Therapeutics announced it is laying off nearly 500 employees this week, including 80 at its Easton location. According to a mass layoff notice filed with the state, biotech company Sarepta ...

Dr. Marty Makary is known for his contrarian views and previously called the FDA “broken,” and “mired in politics” while working for Fox News.

FDA cuts gutted key conflict of interest staff, raising concerns about transparency, advisory panel delays, and drug oversight under the new commissioner.