Zymeworks Inc.
Ziihera
biliary tract cancer
Date
TBD
Approval decision Β· Date TBD estimated
What's at stake
A final FDA approval decision on Ziihera for biliary tract cancer is expected Date TBD.
Primary source
Β· SEC 8-K
verified 13h ago
βIn January 2026, the New Drug Submission for Ziihera was approved by Health Canada for the treatment of adults with previously treated, unresectable locally advanced or metastatic HER2+ (IHC 3+) biliary tract cancer, as monotherapy.β