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FDA to Ask Sarepta to Halt Elevidys Shipments

FDA Will Ask Sarepta to Halt Gene Therapy Shipments After Deaths

The Food and Drug Administration plans to ask Sarepta Therapeutics Inc. to pause shipments of its Elevidys treatment after three deaths were linked to the company’s gene therapies, according to a person familiar with the matter.

Reuters on MSN · 2h

Exclusive: US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.

U.S. News & World Report · 2h

Exclusive-US FDA to Ask Sarepta to Stop Shipments of Gene Therapy Elevidys, Source Says

The agency's scrutiny of Sarepta has sharpened since the deaths of two teenage boys earlier this year who had received Elevidys, a gene therapy approved in the United States to treat a muscle-wasting condition called Duchenne muscular dystrophy.

FDA, JUUL

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The Washington Post · 1d

FDA lets Juul market vapes in the U.S. three years after trying to ban them

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Juul Gets FDA's OK to Keep Selling Tobacco and Menthol E-Cigarettes

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Reuters · 23h

GSK's blood cancer drug fails to secure US FDA advisers' support

The U.S. FDA's panel of independent advisers on Thursday recommended against GSK's blood cancer drug Blenrep, citing concerns about previously documented risks of eye-related side effects, sending the British drugmaker's U.

The Wall Street Journal on MSN · 7h

GSK Shares Drop After FDA Committee Vote Leaves Cancer-Drug Comeback in Doubt

The pharmaceutical company said it remained confident in the benefit and risk profile of Blenrep and will continue to work with the FDA.

Bloomberg on MSN · 12h

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.

US FDA advisers vote against Otsuka's PTSD combination treatment

The U.S. Food and Drug Administration's panel of independent advisers on Friday voted against the efficacy of Otsuka Pharma's ...

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FDA Issues Highest Risk Warning For Dubai Chocolate Recall

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FDA Approves Juul E-Cigs for Sale, Years After Ban Attempt

FRIDAY, July 18, 2025 (HealthDay News) — After years of legal battles and health concerns, Juul Labs has the go-ahead to sell ...

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FDA recalls over 67,000 cases of Power Stick deodorant. See where products were sold

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FDA Issues Risk Warning for Ice Cream Recalled in 23 States

Rich Ice Cream Co. recalled numerous lots of its products on June 27 over potential contamination with Listeria monocytogenes ...

FDA panel reassesses hormone therapy warnings in menopause treatments

The Food and Drug Administration is reassessing some warnings given about hormone therapy treatments for menopause that have ...

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FDA Authorizes Juul’s E-Cigarettes After Ban Nearly Bankrupted Firm

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FDA to Ask Sarepta to Halt Elevidys Shipments

FDA, JUUL

GSK, FDA and Cancer Drug

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