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Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...
The Trump FDA tries to kill a therapy that has helped boys with a deadly diagnosis.
Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to ...
Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the ...
Sarepta will halt all shipments of Elevidys, its drug for Duchenne muscular dystrophy patients, by Tuesday evening.
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, ...
Sarepta Therapeutics said it has paused all shipments of its Elevidys treatment for Duchenne muscular dystrophy in the U.S.
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
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