The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an ...

In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...

Sarepta shares gained even though the U.S. Food and Drug Administration said late Friday that it was probing the death of an ...

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...

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

The FDA is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics to treat Duchenne muscular dystrophy. The child died June 7, prompting ...

Sarepta Therapeutics now trades at book value with strong cash and cost-cutting plans, while ELEVIDYS may regain broader use.

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

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the ...