The FDA has issued a warning to Novo Nordisk regarding unreported safety events for semaglutide. In the warning letter, the FDA said that Novo Nordisk did not adequately respond to comments after the 2025 review. The move is related to safety concerns with the drug semaglutide, used in preparations such as Ozempic and Wegovy. As of July 31, 2025, the FDA recorded a total of 605 adverse event reports related to compressed versions of semaglutide. The warning comes as Novo Nordisk faces multiple FDA regulatory decisions on semaglutide in 2025, including indications for type 2 diabetes and peripheral artery disease. Novo Nordisk also faces allegations of making false and misleading claims in Weg's advertising, including risks such as acute pancreatitis and gallbladder complications.