U.S. Food and Drug Administration issues complete response letter for Byondis' trastuzumab duocarmazine

Byondis

15 May 2023 - Complete response letter outlines FDA's request for additional information.

Byondis today announced that the US FDA has issued a complete response letter for the biological license application for [vic-]trastuzumab duocarmazine (SYD985).

Read Byondis press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Dossier