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

The FDA had halted use in older adults while it investigated reports of side effects. The vaccine’s label now carries new ...

Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.

Monday, the FDA said Sarepta may resume treating ambulatory DMD patients with Elevidys. The recommendation comes just 10 days ...

Sarepta Therapeutics Inc. shares rose sharply early Tuesday after US regulators reversed course and recommended that patients ...

Wall Street analysts suggested the FDA’s unexpected change in stance might reflect pressure from advocacy groups and a rebuke ...

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...

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

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

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

Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug ...