EU Rejections and Setbacks for Duchenne Muscular Dystrophy Gene Therapies

TL;DR Summary
European regulators have decided not to approve the Duchenne muscular dystrophy gene therapy Elevidys, adding to global safety concerns and halting its distribution in Japan and Brazil, with ongoing investigations into safety issues.
- Europe moves to reject embattled Duchenne muscular dystrophy gene therapy statnews.com
- Sarepta-Roche Gene Therapy Fails to Get EU Regulator Approval Bloomberg
- Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU Roche
- CHMP rejects Elevidys in latest setback for Sarepta Yahoo Finance
- Sarepta fails to win EU backing for muscle disorder gene therapy Reuters
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