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FDA to Ask Sarepta to Halt Elevidys Shipments

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.

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. Shares of the company extended losses and were down nearly 35% in afternoon trading,

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.

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 · 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.

1h

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 ...

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 ...

31mon MSN

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 ...

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 ...

8hon 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 ...

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 ...

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 ...

1d

The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market

WASHINGTON (AP) — The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market.

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