12/08/2026 NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC Zipalertinib Combo Achieves PFS Milestone in EGFR Exon 20 NSCLC, FDA Filing Planned NMPA approves ivonescimab + chemo for first‑line advanced squamous NSCLC (Ref) China’s NMPA approved Akeso Bio & Summit Therapeutics' ivonescimab (PD-1 x VEGF) in combination with chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC) The approval was based on the signi

28/04/2026 FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027 FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint FDA accepts NDA for zipalertinib in EGFR exon 20–

20/11/2025 Taiho and Cullinan initiated the rolling submission of a NDA for zipalertinib in EGFR-mutant NSCLC (Ref) Taiho and Cullinan Therapeutics have initiated the rolling submission of a NDA to the US FDA seeking accelerated approval of zipalertinib (EGFR tyrosine kinase inhibitor) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. The submission is based on