17/09/2026 Phase III CELESTIMO study met its primary endpoint of PFS, with Lunsumio + lenalidomid in Follicular Lymphoma OS Therapies announces FDA Alignment on Phase 3 Design and Project Orbis Participation for OST-HER2 in metastatic osteosarcoma US FDA Approves Label Update for IBTROZI (taletrectinib), with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive NSCLC NICE Recommends Enhertu for HER2-Low Advanced Breast Cancer Phase III CELESTIMO study met its prim

02/07/2025 Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma (Ref) Regeneron Pharmaceuticals announced that the US FDA granted accelerated approval for linvoseltamab-gcpt (Lynozyfic; BCMA x CD3 bispecific antibody) for patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody The accelerated a