The agency’s now-reversed decision to halt distribution of a gene therapy for children suffering from muscular dystrophy ...

Vinay Prasad, a top regulator at the US Food and Drug Administration, has left the agency after a controversy over his ...

After our editorial, the agency relents to allow a Duchenne treatment.

Sarepta Therapeutics shares snapped a three-day losing streak on Tuesday, as analysts said resumption of U.S. shipments for ...

Despite all the buzz around Sarepta and concerns about Elevidys, industry watchers aren’t convinced this current controversy ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy ...

The FDA has lifted its hold on Elevidys for ambulatory patients, after asking Sarepta to pause the treatment following three ...

Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...

A timeline of key developments surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys, and the potential ...