Jefferies analysts said these detailed safety outcomes confirm the gene therapy's positive risk/benefit profile in ambulatory ...

Sarepta Therapeutics is selling off Arrowhead Pharmaceuticals’ shares to stretch its cash runway, while also inking a share ...

The last couple of weeks has been particularly distressing for Duchenne muscular dystrophy patients and their families. The fate of Sarpeta’s gene therapy for the disease, called Elevidys, has been ...

CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out ...

After a second Elevidys patient death from acute liver failure, Sarepta in July launched a major restructuring that involves ...

Sarepta Therapeutics said Friday that the deaths of two patients taking its marketed gene therapy Elevidys® (delandistrogene ...

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

Vinay Prasad has stepped down as head of the FDA’s biologics division just two months into the job, following growing backlash over how he handled Sarepta’s Elevidys, the only approved gene therapy ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta Therapeutics hired a Trump-connected lobbying firm after the death of a teenage boy treated with its Duchenne ...

Sarepta Therapeutics Inc.’s shares soared after the US biotech reported revenue that beat estimates, which analysts ...

Since then, regulators’ call for Sarepta Therapeutics to halt shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, and the company’s subsequent decision to do so, have ...