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

06/10/2025 Orca Bio's BLA for Orca-T accepted for Priority Review to treat Hematological Malignancies ( Ref ) The US FDA accepted Orca...

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA...

17/07/2025 Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer ( Ref )...

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC ( Ref ) The US FDA approved...

February 3rd Week, 2025 📝With the Ph3 CHECKMATE-816 trial meeting its key secondary endpoint of OS, BMS’ nivo + platinum-doublet CT...