Sarepta FDA Safety Concerns

News

FDA, Sarepta and gene therapy

Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,

· 1d · on MSN

Sarepta falls as FDA plans to investigate death of child who received Elevidys

· 18h

FDA opens probe into mysterious death linked to gene therapy

BioSpace2d

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 ...

STAT4d

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 ...

The Motley Fool5y

FDA Documents Show Safety Concerns Over a Sarepta Drug

Despite receiving approval, new documents show that the FDA wasn't entirely convinced about the safety of this treatment for Duchenne muscular dystrophy. FDA Documents Show Safety Concerns Over ...

Nasdaq5y

Sarepta shares fall 4% after FDA documents show safety concern about ...

Shares of Sarepta Therapeutics Inc were down around 4% Wednesday after the U.S. Food and Drug Administration revealed documents detailing concerns it had about the safety and efficacy of one ...

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 ...

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