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

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 ...

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

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

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 ...

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular ...

Sarepta said it accepts the CHMP decision on Elevidys, while partner Roche said it will continue working with the EMA.

Sarepta Therapeutics' brutal week continued Friday after European officials rejected the company's controversial gene therapy ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved ...

Friday said that the European Medicines Agency has issued a negative opinion on the conditional marketing authorization for Elevidys, intended for ambulatory patients aged three to seven with Duchenne ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...