28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC ( Ref ) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab  entered a licensing agreement with JMT-Bio Technology (a wholly-

29/09/2025 In an ~$8B deal, Genmab will acquire Merus in an all-cash transaction ( Ref ) Genmab and Merus announced a transaction...

24/09/2025 AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast...

05/09/2025 CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML ( Ref ) The US FDA granted the Fast Track...

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US ( Ref ) Shanghai Henlius Biotech announced...

March 3rd Week, 2025 Regulatory Events   🎯 The US FDA granted traditional approval to Merck & Co./ MSD ’s pembrolizumab (anti-PD-1) +...

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