The U.S. Food and Drug Administration will request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy ...

The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in ...

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

Officials with the Food and Drug Administration have approved the continued sales of tobacco-flavored e-cigarettes and refill ...

A meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...

The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a ...

WASHINGTON (AP) — The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, ...

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...

Lewis Bake Shop is issuing a voluntary recall on their Artisanal Style 1/2 Loaf, which contains undisclosed hazelnuts — a ...

FDA grants priority review to TAR-200, which demonstrated an 82% complete response in high-risk bladder cancer unresponsive ...

The US Food and Drug Administration aims to revoke 52 standards of identity (SOI) across a swath of food categories, claiming ...

The team spent 14 months investigating and found that the FDA had allowed more than 150 potentially unsafe drugs in the U.S.