A young Pittsburgh-area police officer died by suicide and pointed to Lasik eye surgery complications as the reason. Now his ...

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.

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

The pivotal trial for Neurogene's Rett syndrome gene therapy makes use of baseline controls and a rigorous endpoint that ...

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

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 approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults ...