03/06/2026 Terremoto Biosciences Secures FDA Fast Track for AKT1‑Selective Inhibitor TER‑2013 in HR+/HER2– Breast Cancer FDA grants Orphan Drug Designation to Sotio’s LRRC15-targeted ADC SOT106 for osteosarcoma, advancing toward first-in-human trial in 2H26 Lupin & Natco secure FDA approval for Eribulin generic, unlocking $43.7M U.S. market opportunity Verastem’s VS-7375 secures FDA Fast Track for KRAS G12D-mutated NSCLC Amtagvi® (lifileucel) wins conditional TGA approval as

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

12/08/2025 Perioperative pembrolizumab + enfortumab vedotin significantly improved EFS, OS and pCR in cisplatin-ineligible MIBC ( Ref )...