29/09/2026 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program with strategic China funding agreement HUTCHMED announces US NDA Submission for ORPATHYS + TAGRISSO in MET-Driven EGFR-Mutated NSCLC US FDA grants Orphan Drug and Rare Pediatric Disease designations to UTR Therapeutics' MYCN-targeting candidate UTRxMYCN M1-14 Plinabulin secures US FDA Fast Track Designation as BeyondSpring advances Phase 3 DUBLIN-4 NSCLC program

27/09/2026 Aumseqa EU Authorization Revoked Following Regulatory Challenge; Hansoh Pursues Refiling Aumseqa EU Authorization Revoked Following Regulatory Challenge; Hansoh Pursues Refiling (Ref) Hansoh Pharma announced that the European Commission has revoked the EU marketing authorization for lung cancer drug Aumseqa (aumolertinib mesylate tablets; EGFR-TKI) Decision stems from a regulatory procedural issue related to EU data protection requirements and is not associated wit

24/09/2026 US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant OS benefit CSPC reports positive Phase III results for becotatug + osimertinib, demonstrating significant PFS benefit and favorable OS trend in first-Line EGFR Exon20ins NSCLC US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant

31/08/2026 MT027 secures US FDA Fast Track designation for recurrent Glioblastoma FDA clears IDEAYA’s IDE849 Phase 3 path in ES-SCLC In Phase 3 HERIZON-GEA-01 trial, ZIIHERA + chemotherapy demonstrated a statistically significant improvement in OS vs trastuzumab + chemotherapy, meeting the primary endpoint ORPATHYS + TAGRISSO® demonstrated significant PFS benefit with early OS signal in first-line EGFRm NSCLC with MET overexpression Karyopharm files sNDA for selinexor + ruxol

17/08/2026 Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref) AstraZeneca and Daiichi S

21/07/2025 Bayer and Orion Corporation’s Nubeqa™ received EU approval for mHSPC (Ref) The European Commission granted marketing authorization to Bayer and Orion Corporation’s darolutamide (Nubeqa; oral androgen receptor inhibitor) + androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer The approval was based on results from the pivotal Phase 3 ARANOTE trial in which darolutamide + ADT significantly reduced the risk of rad

30/06/2025 Revolution Medicines and Summit entered into a clinical collaboration to evaluate RAS(ON) inhibitors and ivonescimab combinations in RAS Mutant Tumors (Ref) Revolution Medicines and Summit Therapeutics entered into a clinical collaboration to evaluate the safety and efficacy of Revolution Medicines’ daraxonrasib (multi-selective RAS(ON) inhibitor), zoldonrasib (G12D-selective inhibitor) and elironrasib (G12C-selective inhibitor), in combination with Akeso & Summit