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FDA to Ask Sarepta to Halt Elevidys Shipments

Reuters on MSN · 33m

Exclusive-US FDA to ask Sarepta to stop shipments of gene therapy Elevidys, source says

By Bhanvi Satija (Reuters) -The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy Elevidys, a source familiar with the matter told Reuters on Friday.

Bloomberg on MSN · 2h

FDA to Ask Sarepta to Halt Elevidys 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.

CNBC on MSN · 4h

Sarepta shares plunge 30% as future of its gene therapy appears at risk

Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its approved gene therapy appeared at risk. Sarepta has reported three patient deaths related to its gene therapies. The Food and Drug Administration will request that the company voluntarily stop all shipments of the treatment,

FDA Approves JUUL E-Cigs for Sale

Juul gets FDA approval to keep selling e-cigarettes

FDA regulators said Thursday that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping.

UPI on MSN · 1d

FDA approves Juul e-cigarette and cartridge sales

Officials with the Food and Drug Administration have approved the continued sales of tobacco-flavored e-cigarettes and refill cartridges by Juul Labs.

CNN on MSN · 1d

Juul gets FDA’s OK to keep selling tobacco and menthol e-cigarettes

The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend.

39mon MSN

US FDA advisers recommend 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 ...

48m

FDA recalls frozen sprouted beans produced by Sugarland company for links to salmonella outbreak

Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a ...

6hon MSN

FDA Issues Highest Risk Warning For Dubai Chocolate Recall

The Food and Drug Administration has updated their recall of a batch of Dubai chocolate spread to Class I, their highest ...

EatingWell on MSN2d

The FDA Just Approved a New Food Dye, but What Makes It Different?

The FDA just approved Gardenia (genipin) blue, a natural food dye, for certain foods and drinks. They’re also trying to ...

9h

The FDA Announces Recall on Bread Sold at Walmart and Kroger in These States

Lewis Bake Shop is issuing a voluntary recall on their Artisanal Style 1/2 Loaf, which contains undisclosed hazelnuts — a ...

10hon MSN

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 ...

2hon MSN

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 ...

TAG24 on MSN21h

Food and Drug Administration may soon revise hormone replacement therapy warnings

US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels ...

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