The approval makes Wegovy the only GLP-1 therapy cleared to treat adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. About 14.9 million U.S. adults — or roughly 6% of the population — have the condition, according to the FDA.

The Food and Drug Administration has authorized emergency use of animal drugs to treat and prevent infestations of the New World Screwworm, which poses an emerging threat to U.S. livestock and food security.

The U.S. health regulator has allowed a study of Rocket Pharmaceuticals' gene therapy to resume, less than three months after halting it following a patient's death. The drugmaker's shares soared over 30% in morning trading on Wednesday.

The FDA has approved Sisnos’s continuous glucose monitoring (CGM) system for consumer use beyond diabetes management, including weight management support.

In light of this, dermatologist Adam Friedman of the George Washington University has shared with Newsweek how you can choose safe and effective protection.

A little boy in the Chicago area is battling a rare disease and desperately needs a drug treatment for a better life. The drug has not been FDA approved, and it could disappear if it isn't soon.

E (Nasdaq:NVNO) announced today that it received a not-approvable letter from the FDA related to its VenoValve.

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel’s existing dataset.