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

22/09/2025 Nuvalent completed the NDA submission to the FDA for zidesamtinib in ROS +ve NSCLC (Ref) Nuvalent, Inc has completed its NDA submission to the US FDA for zidesamtinib (ROS1-selective macrocyclic tyrosine kinase inhibitor) in TKI pre-treated patients with advanced ROS1-positive NSCLC. SOPHiA GENETICS expanded its collaboration with AstraZeneca for an optimized NGS solution (Ref) SOPHiA GENETICS and AstraZeneca announced an expansion of their collaboration from the W