13/07/2026 FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma GSK’s dostarlimab (aPD-1) delivers sustained complete responses in dMMR/MSI-H rectal cancer FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma (Ref) The US FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for relapsed/refractory multiple myeloma (RRMM) A Prescription Dru

26/11/2025 BeOne's sonrotoclax received the priority review status for R/R MCL (Ref) The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (BCL2 inhibitor) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. The NDA is supported by results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial Lai Wang, Ph.D., Global Head of R&D,

10/09/2025 Greenwich LifeSciences' GLSI-100 received the FDA fast track designation for HER2+ve breast cancer (Ref) The US FDA granted the Fast Track Designation to Greenwich LifeSciences' GLSI-100 (GP2 + GM-CSF) for the treatment of patients with HLA-A*02 genotype and HER2+ve breast cancer who have completed treatment with standard of care HER2/neu targeted therapy. Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, Greenwich: "Greenwich is pleased that the FDA sees the