FDA seeks to withdraw Tavneos approval over manipulated study data
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The FDA wants to pull its 7 October 2021 approval of Tavneos, ChemoCentryx’s drug for a rare autoimmune vasculitis, saying the pivotal trial relied on manipulated data despite only modest remission gains and a narrowly favorable advisory vote. Amgen acquired ChemoCentryx about a year after approval, leaving open whether patients should retain access.
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