The U.S. Food and Drug Administration approved on Friday labeling changes for the blood cancer therapy of Johnson & Johnson ...

The U.S. Food and Drug Administration is reviewing whether to change the warning label on hormone replacement therapy drugs ...

The FDA has accepted for review the sBLA for Afrezza (insulin human) inhalation powder in children and adolescents with type 1 or 2 diabetes.

The Food and Drug Administration (FDA) announced Monday it has begun the process of changing the labeling on acetaminophen to suggest that it may cause autism and ADHD in children whose mothers took ...

Medtronic (NYSE: MDT) announced today that it received new labeling approval from the FDA for its Endurant stent graft system.

Denali Therapeutics has become the latest on a growing list of biotechs to experience an FDA review delay in recent months. | ...

Medtronic announced that the FDA has approved new labeling for the company’s Endurant stent graft system for use in the t ...

Regeneron Pharmaceuticals (NASDAQ:REGN) announced on Friday that the U.S. FDA approved a label expansion for its anti-cholesterol agent Evkeeza, marketed globally with Ultragenyx Pharmaceuticals ...

A change in the safety labels on Tylenol and other acetaminophen products could be a game changer for people claiming they weren’t properly warned about possible links between the pain reliever and ...

WASHINGTON — President Trump and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced new actions the administration is taking to combat autism. According to the department, autism ...