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

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

Biliary tract cancers, encompassing bile duct and gallbladder malignancies, originate from the bile duct epithelium. Cholangiocarcinoma, or bile duct cancer, affects approximately 8,000 individuals annually in the United States, while gallbladder cancer is even less common, with an incidence rate of about 2 per 100,000 people. These cancers are frequently diagnosed at advanced stages, leading to poor prognoses. In the US and EU, treatment options remain scarce, although recen