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The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
Roche’s move came against a backdrop of wider industry retreat from gene therapy, with Pfizer pulling its FDA-approved ...
European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...
Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...
Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...
After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
Roche Holding AG paused all shipments of the controversial gene therapy Elevidys following a similar action by the embattled ...
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...