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BioPharma Dive4d
Sarepta reports patient death in limb-girdle trial, compounding concerns on gene therapy risks
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...
Roche pauses Sarepta gene therapy shipments outside the U.S.
Roche (OTCQX:RHHBY) has decided to pause overseas shipments of Elevidys gene therapy developed by Sarepta Therapeutics ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Sarepta Therapeutics laying off dozens in Ohio, won't comply with FDA request to halt therapy
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
Sarepta Stock Is Falling. How Its Crisis Went From Bad to Worse.
Most investors don’t see the drugmaker’s executive management as credible, following the failure to disclose a patient death, ...
Devdiscourse16h
Roche Pauses Shipments of Muscular Disorder Gene Therapy Elevidys Amid Safety Concerns
Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.