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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 ...
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to ...
There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed ...
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