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

09/06/2026 Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL FDA grants RedHill’s opaganib Rare Pediatric Disease designation for neuroblastoma Serplulimab secures world‑first approval as a chemo‑sparing perioperative immunotherapy for gastric cancer FDA grants RMAT to lasme‑cel, advancing the first off‑the‑shelf CAR‑T into pivotal r/r B‑ALL trial Imugene’s Azer-cel secures FDA Fast Track for CLL/SLL and MZL (Ref) Imugene's Azer-cel (azercabtagene zapreleucel; CD1