Sarepta's gene therapy to be manufactured at Catalent plant with 'operational challenges' this spring
Catalent, the contract manufacturer in the process of overhauling its operations, is manufacturing Sarepta Therapeutics’ newly approved gene therapy for Duchenne muscular dystrophy at one of its plants cited for operational and production challenges.
The FDA on Thursday granted accelerated approval to Elevidys, a one-time gene therapy also known as SRP-9001 or delandistrogene moxeparvovec-rokl, in children who are 4 and 5 years old.
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