The U.S. Food and Drug Administration has requested more data from Eli Lilly regarding its recently approved obesity medication, Foundayo. Regulators are specifically concerned about potential risks for major cardiovascular events and liver damage. This request comes shortly after the agency granted approval for the pill.
The move highlights ongoing regulatory scrutiny of weight-loss drugs, even after they reach the market. Foundayo enters a competitive field dominated by injectable treatments, with oral options seen as a significant market opportunity. Safety profiles remain a critical differentiator in this rapidly expanding therapeutic area.