Weekly Digest – May 2026 Weekly Digest – May 2026 14 May 2026: Astellas Pharma sNDA in Japan for PADCEV in combination with Keytruda for cisplatin-eligible patients with muscle-invasive Bladder cancer Astellas has submitted an sNDA in Japan seeking approval […]
Weekly Digest – May 2026 Weekly Digest – May 2026 08 May 2026: The sNDA for Sacituzumab Tirumotecan in combination with Pembrolizumab as 1L treatment for PD-L1 positive NSCLC accepted for review by NMPA Kelun-Biotech has reached another major regulatory […]
Weekly Digest – May 2026 Weekly Digest – May 2026 11 May 2026: HS-20093 granted Breakthrough Therapy Designation by NMPA for Esophageal cancer treatment Hansoh Pharma has secured another important regulatory milestone after China’s NMPA granted Breakthrough Therapy Designation to […]
Weekly Digest – May 2026 Weekly Digest – May 2026 11 May 2026: SYS6010 has received another BTD in China for the treatment of patients with locally advanced or metastatic ESCC CSPC Pharmaceutical has secured another Breakthrough Therapy Designation from […]
Weekly Digest – May 2026 Weekly Digest – May 2026 12 May 2026: Emiltatug Ledadotin has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of Adenoid cystic carcinoma Servier has secured U.S. FDA Breakthrough Therapy Designation […]
Weekly Digest – May 2026 Weekly Digest – May 2026 11 May 2026: Zai Lab announced that Zocilurtatug Pelitecan has received U.S. FDA FTD for the treatment of extrapulmonary Neuroendocrine carcinomas Zai Lab has received U.S. FDA Fast Track Designation […]
