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Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.
Sarepta stock plummeted Monday after the company said a second patient died following treatment with its Duchenne muscular dystrophy gene therapy, Elevidys. Similar to the first patient, a 16-year ...
Sarepta Therapeutics (NASDAQ:SRPT) and its partner Roche (OTCQX:RHHBY) received a 'go ahead' from the regulatory body in U.K. to lift clinical hold and continue the late-stage study of Elevidys in ...
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