Weekly Digest – August 2026 Weekly Digest – August 2026 04 August 2026: U.S. Food and Drug Administration grants Breakthrough Therapy Designation to Multitude Therapeutics’ AMT-253 Multitude Therapeutics announced that the U.S. FDA has granted Breakthrough Therapy Designation to AMT-253, […]
Weekly Digest – August 2026 Weekly Digest – August 2026 05 August 2026: Multitude Therapeutics’ AMT-676 receives Breakthrough Therapy Designation from China’s CDE Multitude Therapeutics’ CDH17-targeted ADC AMT-676 has been granted Breakthrough Therapy Designation by China’s CDE for the treatment […]
Weekly Digest – August 2026 Weekly Digest – August 2026 03 August 2026: TQB2102 receives BTD from the CDE for patients with unresectable or metastatic HER2-low Breast cancer Sino Biopharmaceutical’s next-generation HER2 bispecific ADC TQB2102 has received its third Breakthrough […]
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 […]
