Weekly Digest – May 2026 Weekly Digest – May 2026 24 April 2026: Novartis withdraws EMA application for adding new indication for Pluvicto Novartis announced that it has withdrawn its Type II variation application with the European Medicines Agency for […]
Weekly Digest – April 2026 Weekly Digest – April 2026 20 April 2026: U.S. FDA grants Priority Review to sBLA for PADCEV + Keytruda as perioperative treatment for MIBC regardless of Cisplatin eligibility U.S. Food and Drug Administration has granted […]
Weekly Digest – April 2026 Weekly Digest – April 2026 22 April 2026: Trastuzumab Ruikang has received BTD from China’s NMPA for the treatment of HER2‑positive breast cancer Jiangsu Hengrui Pharmaceuticals announced that its HER2-targeting ADC Trastuzumab Ruikang in combination […]
Weekly Digest – April 2026 Weekly Digest – April 2026 22 April 2026: SHR‑A2102 has received BTD from China’s NMPA for the treatment of cervical cancer Jiangsu Hengrui Pharmaceuticals announced that its SHR-A2102 ADC has been granted Breakthrough Therapy Designation […]
Weekly Digest – April 2026 Weekly Digest – April 2026 13 April 2026: Ifinatamab Deruxtecan receives U.S. Priority Review for previously treated extensive-stage SCLC progressing after platinum-based chemotherapy Daiichi Sankyo and Merck have received U.S. FDA acceptance and Priority Review […]
Weekly Digest – April 2026 Weekly Digest – April 2026 14 April 2026: GlycoNex receives PMDA approval in Japan to initiate first-in-human phase 1 trial of GNX1021 in gastrointestinal cancers GlycoNex, Inc. has received approval from Japan’s Pharmaceuticals and Medical […]
Weekly Digest – April 2026 Weekly Digest – April 2026 15 April 2026: CSPC Pharmaceutical Group Limited obtains NMPA clinical trial approval for TF-targeted ADC SYS6051 in China CSPC Pharmaceutical Group Limited has received clinical trial approval in China for […]
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 […]
