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Sarepta, Elevidys and FDA

FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy

The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received Sarepta Therapeutics' muscular disorder gene therapy Elevidys. The death occurred on June 7,

Bloomberg on MSN · 20h

FDA Probes Death of Boy in Brazil on Sarepta’s Elevidys

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

MIT Technology Review · 1d

The deadly saga of the controversial gene therapy Elevidys

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

3don MSN

Roche pauses shipments of Elevidys gene therapy outside US

Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside ...

Drugmaker Refuses F.D.A. Request to Pull Treatment Linked to Patient Deaths

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Elevidys, after three patients died from ...

Roche Says CHMP Issued a Negative Opinion on the Conditional Marketing Authorisation for Elevidys

Dow Jones Newswires is a market-moving financial and business news source, used by wealth managers, institutional investors and fintech platforms around the world to identify trading and investing ...

1mon

Roche Pauses Commercial and Clinical Use of Elevidys After Fatal Liver Failures

The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.

EU regulator does not recommend approval of Sarepta's muscle disorder gene therapy

Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' gene therapy Elevidys for a type of rare ...

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