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FDA, Sarepta and Elevidys
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The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...
Children’s Hospital Los Angeles paused the use of Sarepta Therapeutics Inc.’s gene therapy for Duchenne muscular dystrophy in ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
Sarepta Therapeutics (NASDAQ:SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, ...
Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
Shares of drug developer Sarepta Therapeutics surged more than 20% in morning trading, rising after the late-Wednesday news ...
Sarepta agrees to FDA's black box warning and announces major restructuring, including job cuts and cost-saving measures to ...
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