26/08/2026 US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 US FDA Fast Track designation granted for SYS6090 in MSS/pMMR metastatic colorectal cancer Celcuity submits sNDA to US FDA for approval of gedatolisib combination therapy in PIK3CA-mutant HR+/HER2- advanced breast cancer US FDA Fast Track designation granted for SOT106 in Soft Tissue Sarcoma; First-in-Human Trial Planned in late-2026 (Ref) The US FDA h

14/07/2026 FDA frants Fast Track Designation to SOTIO’s SOT109 (CDH17-targeting) ADC for advanced Colorectal Cancer FDA grants full approval to selpercatinib for RET fusion positive solid tumors AstraZeneca secures global rights to Zegfrovy, first oral EGFR exon 20 NSCLC therapy, in $600M upfront deal with Dizal In a Ph3 trial, HBI-8000 + nivolumab improved PFS vs nivolumab + placebo, for advanced Melanoma FDA approved first generics of Gilotrif (afatinib) for EGFR‑mutant and

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