Weekly Digest – October 2025 Weekly Digest – October 2025 29 October 2025: Enhertu approved in Canada as the first and only HER2-directed therapy for patients with HR-positive HER2-low or HER2-ultralow metastatic breast cancer, following disease progression after one or […]
Weekly Digest – October 2025 Weekly Digest – October 2025 30 October 2025: Marketing approval obtained in China for Meiyouheng (Becotatug Vedotin injection) The NMPA has granted marketing approval in China for Becotatug Vedotin injection, an innovative EGFR-targeted ADC developed […]
Weekly Digest – October 2025 Weekly Digest – October 2025 28 October 2025: GSK’s B7-H3-targeted antibody-drug conjugate, GSK’227, receives orphan drug designation in the EU GSK’s B7-H3-targeted ADC, GSK5764227 (GSK’227), has received Orphan Drug Designation (ODD) from the European Medicines […]
Weekly Digest – October 2025 Weekly Digest – October 2025 28 October 2025: Alphamab Oncology announces biparatopic HER2-targeting ADC JSKN003 was granted fast track designation by FDA for the treatment of PROC Alphamab Oncology’s biparatopic HER2-targeting ADC, JSKN003, has received […]
Weekly Digest – October 2025 Weekly Digest – October 2025 27 October 2025: Cellectar Biosciences receives rare pediatric disease designation from U.S. FDA for Iopofosine I 131 in relapsed or refractory pediatric high-grade glioma Cellectar Biosciences received Rare Pediatric Disease […]
Weekly Digest – October 2025 Weekly Digest – October 2025 27 October 2025: GSK acquires exclusive rights from Syndivia for antibody-drug conjugate (ADC) in prostate cancer GSK secured exclusive global rights from Syndivia to develop and commercialize a preclinical antibody-drug […]
Weekly Digest – October 2025 Weekly Digest – October 2025 23 October 2025: Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma The US FDA has approved Blenrep (Belantamab mafodotin) in combination with bortezomib and dexamethasone […]
Weekly Digest – October 2025 Weekly Digest – October 2025 17 October 2025: Core product Trastuzumab botidotin approved for marketing by the NMPA for 2L+ HER2+ breast cancer Sichuan Kelun-Biotech’s core product trastuzumab botidotin (A166) received marketing approval from China’s […]
Weekly Digest – October 2025 Weekly Digest – October 2025 20 October 2025: JSKN003 granted another breakthrough therapy designation in China for the treatment of patients with HER2-positive advanced colorectal cancer JSKN003, a biparatopic HER2-targeting antibody-drug conjugate co-developed by CSPC’s […]
Weekly Digest – October 2025 Weekly Digest – October 2025 21 October 2025: Padcev (Enfortumab vedotin) plus Keytruda (Pembrolizumab) sBLA granted FDA priority review for treatment of certain patients with muscle-invasive bladder cancer The FDA has accepted a supplemental Biologics License […]
