Weekly Digest – May 2026 Weekly Digest – May 2026 22 May 2026: CHMP recommends EU approval of Enhertu for previously treated HER2-positive metastatic Solid tumours AstraZeneca and Daiichi Sankyo have received a positive CHMP opinion for Enhertu in previously […]
Weekly Digest – May 2026 Weekly Digest – May 2026 22 May 2026: Gilead receives CHMP positive opinion for Trodelvy in 1L metastatic TNBC patients ineligible for PD-(L)1 inhibitors Gilead has received a positive CHMP opinion for Trodelvy in the […]
Weekly Digest – May 2026 Weekly Digest – May 2026 25 May 2026: Sino Biopharmaceuticals CLDN18.2 ADC LM-302 granted Priority Review with China approval expected Sino Biopharmaceuticals CLDN18.2-targeted ADC LM-302 has entered China’s priority review pathway, positioning the asset for […]
Weekly Digest – May 2026 Weekly Digest – May 2026 22 May 2026: PADCEV in combination with Keytruda receives positive CHMP opinion for the treatment of patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy Astellas Pharma announced that […]
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 […]
