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

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

28/08/2026 NMPA Approves ATLED (Fanregratinib) for FGFR2+ Intrahepatic Cholangiocarcinoma NMPA Approves ATLED (Fanregratinib) for FGFR2+ Intrahepatic Cholangiocarcinoma (Ref) China’s NMPA has conditionally approved HUTCHMED's ATLED (fanregratinib, HMPL‑453), a selective FGFR1/2/3 inhibitor, for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions/rearrangements after prior systemic therapy The approval is supp

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

29/12/2025 HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma Genmab discontinued the clinical development of acasunlimab following a portfolio review HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma (Ref) China's NMPA accepted and granted priority review status to HUTCHMED Limited's NDA for fanregratinib (FGFR 1/2/3 inhibitor) for the treatment of a