19/02/2026 Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer  Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer ( Ref ) The EMA has validated the type II variation marketing authorization application for AstraZeneca & Daiichi Sankyo's ENHERTU® (trastuzumab deruxtecan; HER2 ADC) monotherapy for adu