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FDA Issues Complete Response Letter for Trastuzumab Duocarmazine in Advanced HER2+ Breast Cancer

The FDA has issued a complete response letter to the biologics license application for vic-trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic breast cancer. ....

United Kingdom , Saura Manich , Marco Timmers , European Union , Drug Administration , Fda Has Issueda Complete Response Letter , Biologics License Application For Vic Trastuzumab Duocarmazine , Her2 Positive Unresectable , Ocally Advanced Or Metastatic Breast Cancer , Phase 3 Tulip Trial ,

EMA validates application for Byondis' trastuzumab duocarmazine

EMA validates application for Byondis' trastuzumab duocarmazine
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United Kingdom , Marco Timmers , European Medicines Agency , Marketing Authorisation Application , European Economic Area ,