Synthetic products posing as kratom mislead and endanger consumers; AKA urges FDA to take decisive action against violative ...

The FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages.

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...

The FDA's breakthrough devices program helps the industry with faster review times, but the benefit to patients is unclear.

Sabores Fit Bakery recalled a variety of its mousse desserts on June 20 because of the undeclared presence of allergens.

The FDA said risks linked to CAR-T cell therapies can be effectively communicated through existing labeling, including boxed ...

Benlysta is the first and only approved autoinjector biologic for both systemic lupus erythematosus and lupus nephritis ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

Starting July 1, North Carolina will enforce a ban on most disposable vapes, following the enactment of House Bill 900.

Olympus is promising swift action to address concerns raised by the Food and Drug Administration (FDA) about some of its ...

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...