News

US regulators said they are investigating the death of an 8-year-old boy who received a gene therapy from Sarepta ...
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 that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics (NASDAQ:SRPT) gene therapy for Duchenne ...
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene ...
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
Sarepta Therapeutics faces an "arduous path” to try to get its gene therapy for Duchenne muscular dystrophy back onto the ...