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Astellas’ Cresemba Review: Orphan Population With Unmet Need Vs. Limited Efficacy Data

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Anti-Infective Drugs Advisory Committee will vote on whether efficacy and safety evidence support approval of Astellas’ antifungal isavuconazonium for two indications, one of which has no controlled data.

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