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US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today issued the ...
The U.S. Food and Drug Administration said on Friday it was investigating the death of an eight-year-old boy who received ...
The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne ...
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 is refusing to pull its gene therapy Elevidys (delandistrogene moxeparvovec), despite a request from the FDA.
After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene ...
The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.
The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.
Elevidys, which is also facing regulatory hurdles in the US, was developed by Sarepta Therapeutics but is sold by Roche outside of the US.
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
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