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

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

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

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

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

Sarepta ( SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the U.S. Food and Drug ...

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

Sarepta Therapeutics Inc. said another patient has died from acute liver failure after receiving one of its gene therapies, putting additional pressure on the biotech company after the recent deaths ...

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

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

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

The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...