Amgen escalated its fight over FDA scrutiny of Tavneos (avacopan) by asking for an independent review, according to reporting on the company’s dispute. The request follows FDA concerns tied to safety issues and allegations of data manipulation connected to litigation involving ChemoCentryx, the original developer of the drug. For Tavneos, the FDA’s review could determine whether the approval stays in place or faces withdrawal, reshaping Amgen’s rare disease exposure and potentially increasing payer and clinician uncertainty. The filing underscores how post-approval compliance disputes can quickly become trial-and-commercialization issues. Amgen’s move also highlights a broader risk pathway for life sciences companies: when safety and trial integrity are contested, regulators can use evidentiary pressure points to revisit benefit-risk judgments—often years after initial approval.