26/06/2026 Henlius’ serplulimab secures EU approval for sqNSCLC FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi Henlius’ serplulimab secures EU approval for sqNSCLC (Ref) The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced

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