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November 21 Product: Jazz and Zymeworks Ziihera Indication: HER2-positive biliary tract cancer With the FDAs approval of Ziihera on Thursday, Jazz Pharmaceuticals and Zymeworks will go toe-to-toe with AstraZeneca and Daiichi Sankyo, whose antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) was given a broad tumor-agnostic approval in April 2024

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Curr Opin Cell Biol (2015) 33:17

Our experience shows that a well-prepared PA with thorough medical justification has a much higher chance of approval