Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

A new study found users of one drug lost almost 50 percent more weight that users of Wegovy. People taking Eli Lilly’s ...

The United States Food and Drug Administration reported a recall by BRS Analytical Services on five eye care products ...

The FDA cleared the investigational new drug application of IDE849, a potential first-in-class DLL3-targeted antibody-drug ...

A salsa product recalled in April due to the possible presence of wood has now been issued a Class II risk classification by the FDA.

The mislabeling of allergens is a leading cause of food recalls in the U.S., and can have serious or life-threatening implications for those with allergies.

The FDA granted Priority Review to lenacapavir for the prevention of HIV as pre-exposure prophylaxis (PrEP). Lenacapavir is a long-acting HIV-1 capsid inhibitor administered as a twice-yearly ...

The FDA has approved Johnson & Johnson’s drug Imaavy for the treatment of generalized myasthenia gravis, a chronic autoimmune neuromuscular disorder. The approval covers adults and pediatric patients ...

A recall of seafood burgers has been updated to the highest risk by the U.S. Food and Drug Administration. Connecticut-based company Caraluzzi’s Markets initiated the recall in April because its ...

Following promising phase 1 data, ISB 2001 has gained fast track designation from the FDA for the treatment of ...

The FDA is asking some of its recently fired staff responsible for critically important funding negotiations with drugmakers ...