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Sarepta Therapeutics, US FDA

Reuters on MSN · 58m

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. Shares of the company extended losses and were down nearly 35% in afternoon trading,

Barron's on MSN · 24m

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

The drop comes the day after the drugmaker said it would add a so-called black-box warning to its gene therapy Elevidys after two teenage boys receiving the treatment died earlier this year.

Bloomberg on MSN · 1h

Patient Deaths Linked to Sarepta Gene Therapy Prompt FDA Probe

The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta Therapeutics Inc. after two patient deaths, adding pressure to the biotech company which also announced a third patient had recently died on a similar treatment.

FDA Approves JUUL E-Cigs for Sale

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.

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.

UPI on MSN · 21h

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.

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 ...

5h

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 ...

BioPharma Dive1h

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 ...

7hon 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 ...

FDA Plans to Revoke 52 Food Standards

HealthDay News — The US Food and Drug Administration has announced a plan to revoke 52 food standards after concluding they ...

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 ...

TAG24 on MSN17h

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 ...

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 ...

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