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FDA to Ask Sarepta to Halt Elevidys Shipments

Reuters on MSN · 58m

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

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

Barron's on MSN · 1h

Sarepta Shares Crash on Report That FDA Will Ask It to Stop Shipping Key Drug

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after two teenage boys receiving the treatment died earlier this year.

Bloomberg on MSN · 44m

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.

FDA, JUUL

UPI on MSN · 23h

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 · 22h

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.

FDA makes Juul’s reign official

The FDA authorized Juul’s applications on Thursday to sell e-cigarettes in the U.S., determining they’re “appropriate for the protection of public health” because their benefits to adult smokers of combustible cigarettes outweigh the risks to nonsmoking youths.

4hon 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 ...

CSP Daily News1h

FDA, FTC warn companies for illegally selling Delta-8 products

Delta-8 is a substance found in the cannabis sativa plant, of which marijuana and hemp are two varieties, the agency said.

BioPharma Dive3h

Panel urges FDA to remove warnings on hormonal menopause therapy

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may ...

7h

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 ...

3don MSN

FDA approves new blue food dye derived from gardenia fruit

The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering ...

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 ...

TAG24 on MSN19h

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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