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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 to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.

Bloomberg on MSN · 1h

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

US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from Sarepta Therapeutics Inc. should remain on the market.

CNBC on MSN · 26m

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, GSK and Cancer Drug

The Wall Street Journal on MSN · 4h

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.

Reuters · 1d

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

The U.S. Food and Drug Administration's panel of independent advisers voted on Thursday against approval of GSK's blood cancer drug Blenrep for use in combination with other treatments.

Bloomberg on MSN · 10h

GSK Falls After FDA Advisory Panel Fails to Back Cancer Drug

GSK Plc shares tumbled after its blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.

FDA Approves JUUL E-Cigs for Sale

Yahoo · 5h

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 · 20h

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 · 20h

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.

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 ...

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 ...

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 ...

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 ...

NBC News on MSN2h

FDA panel reassesses hormone therapy warnings in menopause treatments

The Food and Drug Administration is reassessing some warnings given about hormone therapy treatments for menopause that have ...

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 ...

News Nation on MSN7d

FDA Commissioner: ‘We want to focus on food’

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

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 ...

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