FDA Approves Zanidatamab for Previously Treated, Unresectable …
Nov 21, 2024 · The FDA has granted accelerated approval to zanidatamab for pretreated, advanced HER2-positive biliary tract cancer.
FDA Approves Zanidatamab for Biliary Tract Cancers With High …
Nov 21, 2024 · Learn more about a new treatment for biliary tract cancers with high levels of HER2. The drug zanidatamab has been approved by the FDA, thanks to a clinical trial co-led …
FDA Grants U.S. Approval of Ziihera® (zanidatamab-hrii) for
Nov 21, 2024 · Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial (s). 1 Zanidatamab is not approved …
Positive HERIZON-GEA-01 Phase 3 Results Support Ziihera® (zanidatamab …
Nov 17, 2025 · Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial (s). 5 Zanidatamab is being developed in …
Zanidatamab - Wikipedia
Zanidatamab, sold under the brand name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer. [1][4] It is an IgG-like bispecific HER2 …
Zanidatamab Is a Breakthrough in HER2- Positive Biliary Tract …
Apr 24, 2025 · The recent FDA approval of zanidatamab-hrii (Ziihera; Jazz Pharmaceuticals) marks a pivotal moment in the treatment of unresectable or metastatic HER2-positive (HER2+) …
FDA Approves Zanidatamab in HER2+ Biliary Tract Cancer
Nov 21, 2024 · The FDA granted an accelerated approval to zanidatamab-hrii (Ziihera) for the treatment of patients with previously treated, unresectable or metastatic HER2-positive …
Ziihera (zanidatamab-hrii) FDA Approval History - Drugs.com
Nov 21, 2024 · Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody for the treatment of HER2-positive biliary tract cancer. Ziihera is indicated for the treatment of adults with …
FDA Approves Zanidatamab (Ziihera) for Biliary Tract Cancer
Nov 21, 2024 · The FDA granted accelerated approval to zanidatamab-hrii (Ziihera) for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer.
Zanidatamab-hrii is approved by the USFDA for previously …
Mar 5, 2025 · On November 20, 2024, the Food and Drug Administration granted accelerated approval for zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-targeted …