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

On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just ...

FDA probes Elevidys after an 8-year-old's death in Brazil; Sarepta and Roche say the death was unrelated to gene therapy ...

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

On an investor call Friday, analysts grilled the company over its apparent lack of transparency on the matter.

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...

The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety ...

Sarepta Therapeutics said the Food and Drug Administration informed the company it can lift a voluntary pause on shipments of Elevidys for ambulatory patients with Duchenne. The company said Monday ...

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...

The US Food and Drug Administration (FDA) issued a press release late Friday announcing an investigation into the death of an ...

The U.S. FDA said on Monday that it recommends lifting the voluntary hold on Sarepta Therapuetics' gene therapy, Elevidys, in ...

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