08/01/2026 Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC 858 Therapeutics' ETX-19477 received the FDA fast track designation for BRCA-mutated HGSOC Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC ( Ref ) The US FDA granted the breakthrough therapy designation to Revolution Medicines' zoldonrasib (RAS(ON) G12D-selective inhibitor) for the treatment

13/10/2025 Bicara Therapeutics' ficerafusp alfa + pembro received the breakthrough therapy designation for PD-L1 CPS ≥1, R/M SCCHN pts excluding HPV+ve OSCC ( Ref ) The US FDA granted the breakthrough therapy designation to Bicara Therapeutics' ficerafusp alfa (EGFR x TGF-β bifunctional antibody) in combination with pembrolizumab for the first line treatment of patients with R/M HNSCC whose tumors express PD-L1 CPS ≥1, excluding HPV+ve oropharyngeal squamous cell carcinoma. T

02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma ( Ref ) The US FDA granted...

26/08/2025 Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer ( Ref ) The US FDA...

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA...

24/07/2025 GenFleet Therapeutics and Verastem Oncology's VS-7375 received the Fast Track Designation from the US FDA for pancreatic...