27/04/2026 Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDUFA date of Aug'26 set Tovecimig + paclitaxel significantly improved PFS and ORR in biliary tract cancer; sBLA submission planned FDA Grants Breakthrough Therapy Designation to TERN-701 in Chronic Myeloid Leukemia Relay Therapeutics Advances PI3Kα/CDK4 Triplet Toward Frontline Breast Cancer Phase 3 Trial Zanidatamab combinations receive the FDA priority review status for HER2+ GEA; PDU

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 pati

02/09/2025 Replimune has scheduled a Type A Meeting with the FDA for the CRL of RP1 + nivo in advanced melanoma ( Ref ) Replimune...