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