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Sarepta, gene therapy and FDA

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...

· 1h · on MSN

FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market

· 26m · on MSN

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

FDA, GSK and Cancer Drug

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· 4h · on MSN

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.

· 1d

FDA advisers vote against combination therapies of GSK's blood cancer drug

· 10h · on MSN

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

FDA Approves JUUL E-Cigs for Sale

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· 20h · 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.

HealthDay on MSN · 1h

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

· 20h · on MSN

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

· 19h

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...

· 20h

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

· 22h

Juul will be allowed to sell e-cigarettes ending long fight over flavored tobacco on store shelves

· 23h

FDA reverses ban on sale of Juul e-cigarettes

“Today’s FDA authorization of JUUL products marks an important step toward making the cigarette obsolete,” K.C. Crosthwaite, Juul Labs’s CEO, said in a statement.

· 1d

Juul can continue selling its tobacco and menthol e-cigarettes, FDA says

FOX 29 · 5h

Juul gets FDA approval to keep selling e-cigarettes

2hon 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 level, due to risk of salmonella contamination.

JD Supra42m

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

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.

6hon 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.

BioPharma Dive56m

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.

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 expedite the ban of Red No. 3 before the January 15, 2027, deadline. Some grocers have already pledged not to sell foods with petroleum-based synthetic food dyes.

TAG24 on MSN16h

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.

JD Supra2d

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