News

Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (NASDAQ:SRPT) resumed its recent sell-off on Thursday after Endpoints News reported that the FDA would ...
BioSpace1d
Sarepta’s Future Increasingly Uncertain as FDA Eyes New Study for Elevidys
CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...
Fierce Biotech5d
Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy
The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...
What’s behind Sarepta’s gene therapy deaths?
Three patient deaths linked to gene therapies developed by Sarepta Therapeutics (SRPT) have drawn FDA scrutiny on the viral ...
Sarepta falls as FDA plans to investigate death of child who received Elevidys
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 ...
STAT3d
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 ...
TipRanks on MSN19h
FDA investigating death of child who received Sarepta’s Elevidys
The U.S. FDA is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta (SRPT) Therapeutics gene therapy for Duchenne ...
EconoTimes15h
FDA Probes Death of 8-Year-Old Linked to Sarepta’s Elevidys Gene Therapy
The U.S. Food and Drug Administration (FDA) is investigating the death of an eight-year-old boy who received Sarepta ...
Sarepta fails to win EU backing for muscle disorder gene therapy
Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...
BioPharma Dive5d
5 questions on Sarepta, the FDA and a Duchenne gene therapy crisis
While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...
STAT3d
Pharmalittle: We’re reading about Sarepta’s ‘arduous’ path ahead, pharma’s reliance on China, and more
Sarepta faces an “arduous and treacherous path” to try to get its Duchenne muscular dystrophy therapy Elevidys back onto the ...
FDA asks Sarepta to stop shipping Duchenne gene therapy
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...