Weekly Digest – April 2026 Weekly Digest – April 2026 09 April 2026: The New Drug Application (NDA) for DB-1303/BNT323 for unresectable or metastatic HER2-positive adult breast cancer has been accepted by the NMPA DualityBio’s HER2 ADC DB-1303 (BNT323 / […]
Weekly Digest – April 2026 Weekly Digest – April 2026 07 April 2026: NextCure receives Fast Track Designation for SIM0505 (CDH6 ADC) in ovarian cancer NextCure has received FDA Fast Track Designation for its ADC SIM0505 for the treatment of […]
Weekly Digest – April 2026 Weekly Digest – April 2026 09 April 2026: Celltrion ADC drug candidate CT-P71 receives FDA Fast Track Designation for urothelial carcinoma Celltrion’s ADC candidate CT-P71 has received FDA Fast Track Designation for the treatment of […]
Weekly Digest – April 2026 Weekly Digest – April 2026 07 April 2026: Corbus Pharmaceuticals announces broad alignment with FDA on registration path for CRB-701 in second-line HNSCC and cervical cancer Corbus Pharmaceuticals has achieved broad alignment with the FDA […]
Weekly Digest – April 2026 Weekly Digest – April 2026 30 March 2026: Aktis Oncology announces FDA clearance of Investigational New Drug applications for AKY-2519 Aktis Oncology’s radiopharmaceutical candidate AKY-2519 has received IND clearance from the U.S. FDA, enabling the […]
Weekly Digest – March 2026 Weekly Digest – March 2026 23 March 2026: GSK’s B7-H3-targeted ADC, Risvutatug rezetecan, granted Orphan Drug Designation for small-cell lung cancer in Japan GSK’s investigational B7-H3-targeted ADC, risvutatug rezetecan (Ris-Rez), has received ODD in Japan […]
Weekly Digest – March 2026 Weekly Digest – March 2026 13 March 2026: Alphamab Oncology announces IND application for innovative EGFR/HER3 dual payload bispecific ADC JSKN021 was officially accepted by CDE Alphamab Oncology has achieved a key regulatory milestone, as […]
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 […]
Weekly Digest – October 2025 Weekly Digest – October 2025 23 October 2025: Heidelberg Pharma’s lead ADC Candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma The US FDA granted fast track designation to […]
