15/06/2026 Midstage Pancreatic Cancer Study Fails to Meet Primary Endpoint but Will Advance to Phase 3 FDA accepts ozekibart BLA, setting April 2027 PDUFA for conventional Chondrosarcoma Halia Therapeutics Secures FDA Fast Track Designation for Ofirnoflast in Lower-Risk MDS Menarini Group's Phase 3 SENTRY trial met its first co-primary endpoint, with the selinexor + ruxolitinib combination achieving significant improvement in spleen volume reduction (SVR35) vs ruxolitinib alo

25/08/2025 Quest Diagnostics' Haystack MRD® test received the Breakthrough Device Designation from the FDA for colorectal cancer (Ref) The US FDA granted the Breakthrough Device Designation for Quest Diagnostics' Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. Dan Edelstein, Vice President and General Mana

19/06/2025 Initial patient screening completed in Transgene's Phase 2 trial of TG4050 vaccine in resectable SCCHN (Ref) Transgene completed the initial patient screening in the randomized Phase 2 part of its Phase 1/2 TG4050.02/NCT04183166 trial evaluating TG4050 (individualized neoantigen vaccine) mono as an adjuvant Tx of HPV-ve SCCHN In Ph1 part of the trial, the vaccine elicited promising outcomes with a 2-yr DFS rate of 100.0% Transgene expects to complete randomization