FDA Probes Death of Patient on Sarepta's Elevidys, Partner Roche Says Death Unrelated to Therapy (Reuters) -The U.S. Food and Drug Administration said on Friday it was investigating the death of an ...
Sarepta Therapeutics is navigating a transition from a profitable rare-disease company to a capital-intensive, multi-platform ...
Sarepta has begun evaluating a regimen meant to lower the risk of liver damage in Elevidys recipients. Elsewhere, Inovio laid off staff and a Bayer kidney drug notched another trial victory.
Sarepta Therapeutics has come under pressure following the deaths of three patients using its treatments.
Sarepta (SRPT) will begin shipping its top-selling muscular dystrophy therapy, Elevidys, after the US Food and Drug Administration (FDA) reversed its request for a voluntary pause late Monday. The ...
Although Sarepta Therapeutics managed to defuse a brief stalemate with the FDA earlier this week, the U.S. drug regulator is reportedly going to put the company to work in order to affirm the safety ...
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Shares of Sarepta Therapeutics SRPT rose about 2% yesterday after it announced that screening and enrollment are underway in ...
Sarepta Therapeutics said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, sending the company's shares 59% higher in extended trading. The ...
Sarepta Therapeutics (NASDAQ:SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, in the U.S. The development comes after Sarepta declined to ...
At a mean age of 9 years old, ELEVIDYS-treated patients achieved mean North Star Ambulatory Assessment (NSAA) scores above baseline three years after treatment (n=52) ELEVIDYS gene therapy ...