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Roche pauses Sarepta gene therapy shipments outside U.S.
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The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
Three patient deaths linked to neuromuscular drugs developed by Sarepta Therapeutics (NASDAQ:SRPT) have drawn regulatory ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
Sarepta Therapeutics Inc. shares plunged after European regulators rejected its gene therapy Elevidys, intensifying scrutiny on the drugmaker after it was pressured to halt shipments of its treatment ...
European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
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FDA probes death of patient on Sarepta's Elevidys, partner Roche says death unrelated to therapy
The patient with Duchenne muscular dystrophy, who died in Brazil, was treated with Elevidys but was not a participant in a ...
Sarepta Therapeutics Inc. said Tuesday that its experimental muscular dystrophy drug eteplirsen met its goal in an extension study, and shares of the company more than doubled in ...
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