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US FDA Investigates Third Death After Treatment With Sarepta's Gene Therapy Elevidys
(Reuters) -The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received Sarepta Therapeutics' muscular disorder gene therapy Elevidys. The death occurred on June 7, the agency said.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
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Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an unrelated drug.
Sarepta Therapeutics refused a FDA request to halt shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy ...
The FDA appears to have won its staring contest with Sarepta over shipments of Elevidys, after the company blinked and agreed ...
A Cambridge-based company developing gene therapies for rare diseases is laying off more than a third of its workforce.
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