The FDA proposed withdrawing Amgen’s Tavneos (avacopan) approval after alleging untrue statements of material fact in the approval application. The agency’s Center for Drug Evaluation and Research said the review documents include allegations tied to the dataset supporting the 2021 decision. The move would pull the C5aR antagonist from the market if finalized, escalating a regulatory dispute that began with FDA’s initial concerns and now centers on the integrity of trial analysis. Amgen has previously indicated it would not withdraw the product voluntarily. For the industry, the case reinforces how post-approval scrutiny can escalate quickly from labeling changes to market withdrawal, and it raises the stakes for data transparency and statistical analysis practices in rare-disease approvals.