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

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

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

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

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

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

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

The FDA has reported that the recent death of an 8-year-old boy was unrelated to Sarepta Therapeutics’ gene therapy Elevidys and recommended lifting the voluntary hold on the treatment, which is used ...

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 ...

Shares of Sarepta Therapeutics plummeted Friday following a report that a third patient has died during a clinical trial for ...

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

Shortly after the U.S. FDA announced an investigation into the death of a patient who had received Elevidys, a gene therapy ...