The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its ...

Sarepta Therapeutics shares jumped over 36% in premarket trading on Tuesday after the company said it had received US Food ...

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, ...

As mothers of children with this disease, we have wept helplessly in recent months as friends — fellow members of a club we ...

The pharma company said it would lay off a third of its workforce and add a black-box warning to its controversial gene ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...