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

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

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 Takeda’s new immunoglobulin therapy, Gammagard liquid ERC [immune globulin infusion (human)], to treat ...

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

Endoscopy devices restricted from import accounted for about 1% of the company’s consolidated revenue in its latest fiscal ...

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