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

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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

FDA Approves JUUL E-Cigs for Sale

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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.

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

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

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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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US FDA Approves Juul's E-Cigarettes, Source

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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.

GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations. The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

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

Health officials have recalled two products produced by Chenak LLC, which has a location in Sugarland, for ties to a salmonella outbreak.

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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.

The Vaping Giant That Almost Died: JUUL's Shocking FDA Reversal

In a significant reversal and a major boost for the embattled vaping company, the U.S. Food and Drug Administration (FDA) on Thursday authorized the marketing of five JUUL Labs Inc. e-cigarette products,

CBO finds health agency cuts would result in fewer new drugs

Potential NIH and FDA cuts could lower the number of new drugs that come to market in the next three decades, according to a CBO analysis.

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FDA plans to revoke 52 food standards

The U.S. Food and Drug Administration has announced a plan to revoke 52 food standards after concluding they are "obsolete and unnecessary."

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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.

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The FDA Just Approved Another Natural Food Dye for Use in Several Common Snacks and Drinks

On Monday, July 14, the FDA announced that it has approved the use of the natural color additive gardenia (genipin) blue for dying a variety of foods and drinks. This is the fourt