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 ...

CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy: Basel Monday, July 28, 2025, 15:00 Hrs [I ...

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

The company can again ship the Duchenne gene therapy for patients who can still walk, following a one-week pause triggered by ...

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

Sarepta Therapeutics (SRPT) shares dropped sharply on Monday following news that the FDA is investigating a patient death potentially connected to its gene therapy, Elevidys.

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

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy. The company's stock has been under pressure for ...

The FDA has partially reversed course on its push to halt shipments of a controversial gene therapy made by Sarepta ...

The FDA is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics to treat Duchenne muscular dystrophy. The child died June 7, prompting ...

The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta (SRPT) Therapeutics gene ...