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

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

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

Shipment of delandistrogene moxeparvovec, a gene therapy for Duchenne muscular dystrophy (DMD), will resume following a ...

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

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

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

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

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

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 ...

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

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