The FDA asked Eli Lilly to provide additional data to assess cardiovascular and liver risks for Foundayo, the company’s newly approved obesity pill. The request reflects the agency’s concern about major adverse cardiovascular events and potential liver damage, requiring expanded evidence for the safety profile. The timing underscores heightened post-approval scrutiny for new obesity agents as sponsors finalize pharmacovigilance plans and additional analyses. Lilly will need to respond with clinical and/or nonclinical data aligned to FDA’s risk concerns before the evidence base can fully stabilize. For clinicians and payers, the information could affect how quickly evidence is used to refine patient selection for the therapy.