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 · 21h

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 · 17h

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

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, ...

Makary ally named to key FDA drug post

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

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 ...

10hon MSN

Zepto & Blinkit On The Radar Of The Maharashtra Food & Drug Administration For Inspection Of Dark Stores

Zepto and Eternal's quick-commerce arm Blinkit are on the radar of the Maharashtra Food and Drug Administration (FDA) for ...

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 ...

Yahoo2mon

How the FDA's Milk Testing Pause Affects Your Child's Safety

By now, you have likely heard that the Food and Drug Administration (FDA) has suspended its testing procedures for milk in the U.S. But the information that has been dispersed online about this ...

ConsumerAffairs8d

FDA greenlights Juul’s e-cigarettes

FDA authorizes Juul’s tobacco- and menthol-flavored e-cigarettes to stay on U.S. shelves, reversing a previous ban due to new ...

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