FDA Unable to Approve Narsoplimab for HSCT-TMA Without More Data
Cardiovascular Disease General Hematologic Disorders Leukemias/lymphomas/ And Other Hematologic Cancers News Thromboembolic Disorders

FDA Unable to Approve Narsoplimab for HSCT-TMA Without More Data

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Omeros Corporation regarding the Biologics License Application (BLA) for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).…

FDA: New Warnings and Limitations Set for Certain JAK Inhibitors
Arthritis/rheumatic Disorders Cardiovascular Disease General Musculoskeletal Disorders News Oncology Rheumatoid Arthritis Thromboembolic Disorders

FDA: New Warnings and Limitations Set for Certain JAK Inhibitors

The Food and Drug Administration (FDA) is requiring revisions to the Boxed Warning for Xeljanz (tofacitinib), Xeljanz XR (tofacitinib extended-release), Olumiant (baricitinib), and Rinvoq (upadacitinib) to include information about the risks of serious cardiovascular-related events,…