12/10/2026 Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer In Phase 3 ACTION-1 trial, RYZ101 met primary endpoint of PFS in patients with GEP-NETs HLB/Elevar Resubmits US FDA application for first-line Liver Cancer combination US FDA grants Fast Track Designation to AST-301 for HER2-Positive Gastric Cancer Opamtistomig (PD-L1 x 4-1BB BsAb) receives US FDA Fast Track Designation in First-Line Biliary Tract Cancer (Ref

23/09/2026 US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma SOTIO Advances SOT106 with Additional FDA Designations in Sarcoma In Phase 3 MajesTEC-3 study, TECVAYLI + DARZALEX FASPRO demonstrates durable survival outcomes and substantial progression risk reduction in RRMM US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma (Ref) Elevar Therapeutics announced US FDA approval of LYRFIGTU™ (lirafugratinib), an irreversible

22/09/2026 US FDA requests additional OS evidence for Tovecimig in Biliary tract cancer despite positive COMPANION-002 efficacy results US FDA Conditionally Accepts LYRFIGTU™ Brand Name for Lirafugratinib US FDA requests additional OS evidence for Tovecimig in Biliary tract cancer despite positive COMPANION-002 efficacy results (Ref) Compass Therapeutics provides regulatory update on feedback received from the US FDA regarding Tovecimig (DLL4 × VEGF-A bispecific antibody) for

10/07/2026 FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance Risvutatug Rezetecan delivered first Phase III overall survival benefit vs topotecan, in relapsed small cell lung cancer FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance (Ref) Elevar Therapeutics announced on that the FDA declined to approve its combination therapy of rivoceranib (VEGFR TKI) and camrelizumab (anti–PD-1) as a first-line trea

30/03/2026 Zymeworks' ZW191 ADC received the FDA fast track designation for PROC Elevar Therapeutics' NDA for lirafugratinib received priority review status from the FDA for cholangiocarcinoma Henlius Biotech's serplulimab + chemo received positive CHMP opinion for NSCLC and ESCC Zymeworks' ZW191 ADC received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Zymeworks Inc's ZW191 (FRα-targeting ADC) for the treatment of patients

28/01/2026 Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib as a 2L treatment for cholangiocarcinoma (Ref) Elevar Therapeutics submitted a NDA to the US FDA for lirafugratinib (FGFR2 inhibitor) as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement. Dong-Gun Kim, the company’s chief executive offi