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

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

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

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

Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump ...

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 ...

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 ...

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 ...

The Department of Health and Human Services (HHS) is laying off certain employees who were notified months ago of the ...

President Donald Trump's proposed budget cuts to the National Institutes of Health would eventually result in fewer drugs on ...

Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...