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Tag Archives: FDA inaction

The Never-Ending TAVNEOS Story

Posted on October 25, 2026 by Harald — No Comments ↓

The Tavneos story is getting more bizarre by the day:  since January 2026 FDA is haggling with Amgen about a withdrawal.  The Agency’s reasoning is described in detail in their April 26 statement and mentioned in numerous Pharma newsletters.  The key issue is and was the unblinded re-adjudication of the Continue reading The Never-Ending TAVNEOS Story→

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Posted in Did you know...?, The News, The Viewpoint | Tagged ADVANCE study, Allphase Pharma Consulting, Amgen, ANCA vasculitis, Avacopan, Chemocentryx, CHMP, complement C5aR inhibitor, data re-adjudication, DCRI, EMA, FDA, FDA inaction, Harald Reinhart, MHRA, Tavneos | Leave a reply

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