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FDA to Ask Sarepta to Halt Elevidys Shipments

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

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

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FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

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

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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 Therapeutics, Inc. (SRPT) Strategic Restructure and ELEVIDYS Label Update Call Transcript

salmonella, frozen sprouted beans and FDA recalls

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FDA recalls frozen sprouted beans produced by Sugarland company for links to salmonella outbreak

The CDC recommends customers who purchased the products to dispose of them immediately and thoroughly wash items or surfaces that came in contact with the sprouted beans.

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Frozen sprouted beans linked to salmonella outbreak recalled

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CDC warns of salmonella outbreak in frozen beans

FDA, JUUL

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· 1d · 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.

· 1d · on MSN

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

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FDA makes Juul’s reign official

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

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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.

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

FOX 29 · 10h

Juul gets FDA approval to keep selling e-cigarettes

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US FDA advisers recommend 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 antipsychotic drug in combination with Viatris' antidepressant Zoloft for treating adults with PTSD.

10h

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.

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.

Food Business News11h

FDA targets 52 food standards of identity for termination

The US Food and Drug Administration aims to revoke 52 standards of identity (SOI) across a swath of food categories, claiming the regulations are “obsolete and unnecessary.” Under the proposal, announced July 16,

BioPharma Dive6h

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.

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 foods are often targeted toward children and said the agency has focused on fighting childhood obesity and diabetes.

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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 drug when used in combination with Viatris' Zoloft for the treatment of adults with PTSD.

TAG24 on MSN22h

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.