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 hits just keep on coming for Regeneron’s Eylea franchise. | The FDA has extended its target action dates for two applications to expand the use of Eylea’s high-dose formulation. The U.S. regulator was originally scheduled to make its Eylea HD decisions by Aug.

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.

The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient evidence of efficacy in patients with Friedreich’s ataxia.

More than two years after the Food and Drug Administration held a public workshop on measuring overall survival (OS) in clinical cancer trials, the agency has released a