FDA Drug Safety Suspensions

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gene therapy, FDA and 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.

Bloomberg on MSN · 8d

Sarepta Refused FDA’s Request to Halt Elevidys Shipments

The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta Therapeutics Inc. after two patient deaths, adding pressure to the biotech company which also announced a third patient had recently died on a similar treatment.

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

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 ...

Devdiscourse13d

Reputed Pune Eatery Faces Licence Suspension Over Hygiene Concerns

The Maharashtra FDA temporarily suspended the licence of Pune's renowned 'Cafe Goodluck' after a video allegedly showing ...

Black Enterprise3mon

The FDA Eliminates Key Staff Overseeing Food Safety - Black Enterprise

The U.S. Food and Drug Administration is rolling back America's food safety programs. The U.S. Food and Drug Administration (FDA) has significantly reduced oversight for food safety, ...

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 ...

FDA reaches out to more than 5k eateries over food safety in a year, but hygiene remains a concern

Pune: A string of recent food safety violations at popular eateries in the city has turned the spotlight onto lax sanitation ...

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