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

US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

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 ...

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

Elevidys is an adeno-associated virus vector-based gene therapy that uses Sarepta’s AAVrh74 Platform Technology to treat DMD, ...

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

The Food and Drug Administration has paused distribution of the gene therapy Elevidys following the death of a third patient ...

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

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

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

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne ...