13/08/2026 US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma Celltrion announced that CT-P73, tissue factor–targeting ADC for recurrent/metastatic cervical cancer, received FDA fast track designation US FDA Grants Type C Meeting to Review OST-HER2 Survival Data in Osteosarcoma (Ref) OS Therapies announced that the US FDA has granted a Type C Statistical Methods meeting to review 2.5-year overall survival data from the Phase 2b OST-HER2 trial in pul

09/04/2026 NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer Celltrion Wins Dual FDA Fast Track Approvals for ADC Pipeline Satri-cel: First CAR-T Therapy for Solid Tumors Set to Launch in China NMPA Accepts NDA for DB-1303/BNT323 in HER2+ Metastatic Breast Cancer (Ref) The New Drug Application (NDA) for DualityBio and BioNTech's DB-1303/BNT323 (Trastuzumab Pamirtecan, T-Pam; HER2‑targeted ADC) has been accepted by China’s National Medical Products Administ