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

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

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 (NASDAQ:SRPT) resumed its recent sell-off on Thursday after Endpoints News reported that the FDA would ...

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...

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

Morning. Today, we discuss how Duchenne patients and their families are responding to the shelving of Sarepta Therapeutics’ ...

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

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...

This week's episode covers news about Sarepta, babies born following mitochondrial transfer, and AI identifying therapy ...

Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the ...