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 patients

02/09/2025 Replimune has scheduled a Type A Meeting with the FDA for the CRL of RP1 + nivo in advanced melanoma (Ref) Replimune announced that a Type A meeting with the US FDA has been scheduled to discuss the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with GALV-GP R- and GM-CSF) + nivolumab for the treatment of advanced melanoma. Replimune submitted a briefing book to the FDA addressing the points from the CRL T