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FDA Informs Sarepta That It Recommends That Sarepta Remove Its Pause and Resume Shipments of ELEVIDYS for Ambulatory Individuals With Duchenne Muscular Dystrophy

- Sarepta and FDA will continue dialogue on next steps in the safety labeling process and risk-mitigation approach for non-ambulatory patients CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, ...
The American Journal of Managed Care

FDA Recommends Sarepta Resume DMD Gene Therapy Shipments for Ambulatory Patients

The FDA lifted the pause on delandistrogene moxeparvovec shipments for ambulatory patients with Duchenne muscular dystrophy (DMD) after a safety review. The pause was due to acute liver ...
GEN

Sarepta to Resume Shipping DMD Gene Therapy to Ambulant Patients

Sarepta Therapeutics said it will resume shipments of its gene therapy Elevidys ® (delandistrogene moxeparvovec-rokl) “imminently” to ambulant patients with Duchenne muscular dystrophy (DMD), ending a ...
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FDA Informs Sarepta That It Recommends That Sarepta Remove Its Pause and Resume Shipments of ELEVIDYS for Ambulatory Individuals With Duchenne Muscular Dystrophy

- Sarepta and FDA will continue dialogue on next steps in the safety labeling process and risk-mitigation approach for non-ambulatory patients Sarepta will resume shipping ELEVIDYS to sites of care ...