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Tuesday, July 2, 2024

Vertex Acceptance of Application for Triple Combination Treatment for Cystic Fibrosis

 - Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 –

- EU Marketing Authorization Application (MAA) submission also validated by European Medicines Agency (EMA)

https://www.biospace.com/article/releases/vertex-announces-fda-acceptance-of-new-drug-application-for-vanzacaftor-tezacaftor-deutivacaftor-a-next-in-class-triple-combination-treatment-for-cystic-fibrosis/

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