Weekly Digest – August 2026 Weekly Digest – August 2026 03 August 2026: U.S. FDA grants Orphan Drug Designation to Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan for the treatment of Neuroendocrine Carcinomas Zai Lab’s DLL3-targeting ADC Zocilurtatug pelitecan has received […]
Weekly Digest – July 2026 Weekly Digest – July 2026 28 July 2026: DualityBio and BioNTech’s B7-H3 ADC DB-1311 granted China NMPA BTD for metastatic castration-resistant Prostate cancer DualityBio and BioNTech announced that China’s NMPA has granted Breakthrough Therapy Designation […]
Weekly Digest – July 2026 Weekly Digest – July 2026 24 July 2026: Gilead announces CHMP recommendation for Trodelvy + Keytruda in 1L PD-(L)1+ mTNBC Gilead announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has […]
Weekly Digest – July 2026 Weekly Digest – July 2026 24 July 2026: EU CHMP recommends Enhertu plus Pertuzumab for 1L HER2 metastatic Breast cancer AstraZeneca and Daiichi Sankyo announced that the European Medicines Agency’s Committee for Medicinal Products for […]
Weekly Digest – July 2026 Weekly Digest – July 2026 21 July 2026: SEC recommends approval to Enhertu for two additional indications in India India’s Subject Expert Committee has recommended approval of two additional indications for AstraZeneca and Daiichi Sankyo’s […]
Weekly Digest – July 2026 Weekly Digest – July 2026 14 July 2026: SOTIO receives FDA Fast Track Designation for CDH17-targeting ADC SOT109 for CRC SOTIO has received U.S. FDA Fast Track Designation for SOT109, its CDH17-targeting antibody-drug conjugate, for […]
Weekly Digest – July 2026 Weekly Digest – July 2026 02 July 2026: SYS6043 granted BTD in China for the treatment of platinum-resistant Ovarian cancer CSPC Pharmaceutical Group has received Breakthrough Therapy Designation from China’s NMPA for SYS6043, a B7-H3-targeted […]
Weekly Digest – July 2026 Weekly Digest – July 2026 02 July 2026: Glenmark advances phase 3 trial of Trastuzumab rezetecan in platinum-resistant Ovarian cancer Glenmark has advanced the multi-country phase 3 clinical trial of SHR-A1811, a HER2-targeted antibody-drug conjugate, […]
Weekly Digest – June 2026 Weekly Digest – June 2026 23 June 2026: NMPA accepts Tecotabart Vedotin NDA for third-line CLDN18.2+ Gastric cancer The NDA for LM-302, a CLDN18.2-targeting antibody-drug conjugate developed by Sino Biopharmaceutical, has been accepted by China’s […]
Weekly Digest – June 2026 Weekly Digest – June 2026 16 June 2026: Zai Lab’s Zocilurtatug pelitecan receives EMA Orphan Drug Designation for pulmonary Neuroendocrine carcinoma Zai Lab has received Orphan Drug Designation from the European Medicines Agency for Zocilurtatug […]
