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FDA Probes Death of Patient on Sarepta's Elevidys, Partner Roche Says Death Unrelated to Therapy
(Reuters) -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, the agency said.
Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...
Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' gene therapy Elevidys for a type of rare ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
To suggest Sarepta Therapeutics may not survive its gene therapy crisis is a sobering claim to make, STAT's Adam Feuerstein ...
Sarepta Therapeutics' licensing partner Arrowhead Pharmaceuticals said on Wednesday it expects to receive near-term milestone ...
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