Sarepta FDA Safety Concerns - Search News

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US FDA Investigates 3rd Death

Seeking Alpha on MSN · 1d

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 require the company to conduct new studies to address safety concerns and reintroduce its gene therapy,

EconoTimes · 6h

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 Therapeutics (NASDAQ: SRPT) gene therapy, Elevidys, for Duchenne muscular dystrophy (DMD).

TipRanks on MSN · 10h

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

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 Biotech4d

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 ...

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 ...

10hon MSN

Sarepta fails to win EU backing for muscle disorder gene therapy

Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...

3don MSN

Sarepta pares gains as report suggests an ‘arduous’ path for Duchenne drug

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to ...

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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