A series of panels convened by the Food and Drug Administration is raising concerns that the agency is skirting federal rules ...

The Food and Drug Administration approved the weight loss drug Wegovy to treat an increasingly prevalent liver disease on ...

The once-a-day, under-the-tongue tablet will be commercially available in the fourth quarter. Tonix said that Tonmya is the ...

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

Families concerned about color additives in school lunches, at grocery stores and at fast-food counters can now reference a ...

The FDA said in letters to five sunscreen makers that they are not authorized to market sunscreen sold in mousse or whipped form.

The U.S. Food and Drug Administration has approved Tonix Pharmaceuticals' drug to manage pain related to a type of chronic ...

The U.S. Food and Drug Administration has approved Insmed's daily bronchiectasis pill, brensocatib, which will be sold under ...

Lead is toxic to people of any age or health status and higher exposure levels can lead to neurological changes ...

In a highly unusual move, a small biotech has disclosed a rejection letter from the FDA in hopes of rallying support for ...