Tag: Biological License Application
Food and Drug Administration Issues Complete Response Letter for Byondis’ [Vic-]Trastuzumab...
Earlier this week, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for Byondis' Biological License Application (BLA) for the company's anti-HER2 antibody-drug conjugates [vic-] trastuzumab duocarmazine, also known as SYD985.