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

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

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

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

FDA recommends lifting the hold on Sarepta's gene therapy Elevidys for ambulatory patients after investigation; ...

Sarepta Therapeutics (SRPT) in focus as the biotech says the death of a patient who had received its gene therapy Elevidys ...

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

This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially ...

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 ...

Shipments of Elevidys for nonambulatory DMD patients remain suspended while the Company evaluates an enhanced immunosuppressive regimen for these patients.

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

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