The European Medicines Agency opened a review of Amgen’s vasculitis drug Tavneos (avacopan) after receiving new information that raised questions about data integrity in the ADVOCATE study underpinning the original approval. The EMA said the concerns relate to how study data were handled and may have impacted efficacy findings; the review is underway. Separately, Amgen announced it would stop development of an eczema candidate after disappointing Phase III results, returning the asset to its partner. The twin developments underscore regulatory and clinical hurdles facing big‑biotech pipelines even after prior approvals or late‑stage investments. For regulators and developers, the Tavneos review highlights increased scrutiny on trial data handling and quality; for investors, it emphasizes the potential for regulatory action to materially affect marketed and pipeline assets.