Details Basic Details Approval Date Wednesday, February 1, 2023 Original Posting Date Friday, March 15, 2024 Health Outcome(s) malignancy, gastrointestinal (GI) bleed, heart failure, major adverse cardiovascular events, venous thromboembolism (VTE), adverse pregnancy and fetal outcomes, retinopathy proliferative, drug induced liver injury Regulatory Link(s) (2) FDA Approval Package ARIA Memo