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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.

· 1h · on MSN

FDA to Ask Sarepta to Halt Elevidys Shipments After Deaths

· 3h · on MSN

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

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

Sarepta Therapeutics laid off more than one-third of its workforce, or approximately 500 employees, the company announced Wednesday — a drastic cost-cutting move following the deaths of two teenagers...

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

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Sarepta shares slump on reports of third patient death this year

salmonella, frozen sprouted beans and FDA recalls

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· 1h · on MSN

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.

· 1d · on MSN

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

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...

· 1d · on MSN

FDA approves Juul e-cigarette and cartridge sales

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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 · 9h

Juul gets FDA approval to keep selling e-cigarettes

30mon MSN

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.

7hon 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.

Food Business News10h

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,

3don MSN

FDA approves new blue food dye derived from gardenia fruit

The U.S. Food and Drug Administration approved a new blue color additive derived from the fruit of the gardenia, a flowering evergreen, for use in a variety of drinks and candies.

11hon 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.

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.

2hon MSN

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 MSN21h

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.