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

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

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

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

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

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

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

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

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

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

As a new variant that causes 'razor blade throat' spreads, the FDA updates vaccine warnings to include information on heart ...

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...