FDA Muscular Dystrophy Drug Suspension

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FDA, Sarepta

FDA opens probe into mysterious death linked to gene therapy

The Food & Drug Administration is investigating the death of an 8‑year‑old following Elevidys gene therapy for Duchenne muscular dystrophy. U.S. distribution has been paused amid safety concerns.

GEN - Genetic Engineering and … · 1h

FDA Probes Death of Brazilian Boy Linked to Sarepta’s Elevidys

The FDA is investigating the death last month of an eight-year-old boy in Brazil who had received Sarepta Therapeutics’ Elevidys® (delandistrogene moxeparvovec-rokl)—though the company and its overseas partner quickly countered that his death was unrelated to treatment with the Duchenne muscular dystrophy gene therapy linked to two of the company’s three patient deaths this year.

Clinical Trials Arena on MSN · 5d

Sarepta halts Elevidys shipments following FDA pressure

Sarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.

6don MSN

FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

4don MSN

Sarepta shares slide again as drugmaker bows to FDA pressure to pause gene therapy

Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

InvestorsHub on MSN5d

Sarepta Shares Drop as FDA Suspends Gene Therapy Trials for Muscular Dystrophy

Shares of Sarepta Therapeutics Inc (NASDAQ:SRPT) plunged 10% after the company disclosed that the U.S. Food and Drug ...

Fierce Pharma5d

Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys

A brief skirmish between Sarepta Therapeutics and the FDA has ended before escalating into a full-on regulatory clash, as the company has bowed to the agency’s demand. | A brief skirmish between ...

STAT16d

FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

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