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FDA Will Ask Sarepta to Halt Gene Therapy Shipments

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.

· 2h · on MSN

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

· 2h · on MSN

FDA Will Ask Sarepta to Halt Gene Therapy Shipments After Deaths

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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 (SRPT.O) to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Fri...

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Sarepta Therapeutics lays off one-third of workforce in drastic cost-cutting

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Sarepta shares slump on reports of third patient death this year

FDA Approves JUUL E-Cigs for Sale

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· 22h · on MSN

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.

· 7h

Juul gets FDA approval to keep selling e-cigarettes

· 22h · on MSN

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

· 21h

FDA approves Juul's tobacco and menthol e-cigarettes

Juul Labs said on Thursday the U.S. Food and Drug Administration has authorized the sale of its e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with h...

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F.D.A. Approves Juul Vapes After Yearslong Delay

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

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That Dairy Queen cone that’s cooling you off can’t legally be called ‘ice cream,’ FDA says — here’s why

Though the regulations and labeling changed, Dairy Queen’s recipe never did. Now Dairy Queen’s soft serve qualifies as “reduced-fat ice cream” — but that’s still not ice cream in the FDA’s eyes. However, it should be noted that just because DQ’s soft serve has just 5% milk fat, that doesn’t mean it’s 95% fat-free.

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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 level, due to risk of salmonella contamination.

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 danger to those with a sensitivity.

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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 hot flashes.

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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.

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FDA Plans to Revoke 52 Food Standards

HealthDay News — The US Food and Drug Administration has announced a plan to revoke 52 food standards after concluding they are “obsolete and unnecessary.” The 52 food standards pertain to canned fruits and vegetables, dairy products, baked goods, macaroni products, and other foods.

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 on Hormone Replacement Therapy.

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Recent FDA Actions Pose Big Changes and Questions for Health and Food Industries

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and