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

06/05/2026 FDA grants Fast Track designation to Diakonos Oncology’s DOC1021 immunotherapy for advanced melanoma, advancing a novel dendritic cell therapy into Phase 1/2 trials Partner Therapeutics secures FDA Priority Voucher for BIZENGRI in NRG1+ cholangiocarcinoma, advancing rapid review of Phase 2 eNRGy data FDA accepts sNDA for IBTROZI® with >4‑year median response in ROS1+ NSCLC, reinforcing long‑term efficacy and global standard‑of‑care potential FDA grants Fast Track d