FDA Drug Safety Suspensions

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FDA, Sarepta and Elevidys

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.

U.S. News & World Report · 1d

FDA Probes Death of Patient on Sarepta's Elevidys, Partner Roche Says Death Unrelated to Therapy

The reporting physician has assessed the death as unrelated to treatment with the gene therapy, Roche said, adding that the death was reported to the health authorities as require

TipRanks on MSN · 1d

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

Clinical Trials Arena on MSN4d

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.

SPRITAM® (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube Administration

Aprecia, the global leader in 3DP (three-dimensional print) technology for commercial-scale pharmaceutical manufacturing, today announced that the U.S. Food and Drug Administration (FDA) has approved ...

Makary ally named to key FDA drug post

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty ...

BioSpace4d

Sarepta Concedes to FDA Request, Suspends US Shipments of Elevidys

After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, ...

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...

Fierce Pharma4d

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 ...

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