FDA Drug Safety Suspensions

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Sarepta, gene therapy and FDA

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.

MPR · 5d

Third Death Prompts FDA Action on Sarepta’s Gene Therapy Products

The third death occurred in an adult male with limb girdle muscular dystrophy who received a Sarepta AAVrh74 gene therapy product, SRP-9004, in a phase 4 clinical trial.

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

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.

5don MSN

FDA names former pharmaceutical company executive to oversee US drug program

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

Fierce Pharma3d

Roche halts Elevidys distribution in some countries, following Sarepta's lead in US

Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...

BioPharma Dive4d

Sarepta stops Elevidys shipments after standoff with FDA

Company CEO Doug Ingram said the pause was necessary for Sarepta to maintain a "productive and positive working relationship" ...

Makary ally named to key FDA drug post

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

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 ...

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 ...

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