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Elevidys, Sarepta and FDA

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.

· 23h · on MSN

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

MIT Technology Review · 1d

The deadly saga of the controversial gene therapy Elevidys

· 7h

What’s behind Sarepta’s gene therapy deaths?

Three patient deaths linked to neuromuscular drugs developed by Sarepta Therapeutics ( NASDAQ: SRPT) have drawn regulatory scrutiny on the viral vector used in the company’s gene therapy platform tech...

STAT · 1d

Europe moves to reject embattled Duchenne muscular dystrophy gene therapy

· 1d

EU panel declines backing Sarepta-Roche gene therapy for Duchenne

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 the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics .

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.

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

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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 muscular dystrophy, the health agency said on Friday.