The European Medicines Agency (EMA) has recommended withdrawing marketing authorization for Amgen and Vifor’s Tavneos (avacopan), citing data integrity problems with the basis of approval. A separate EMA action says the CHMP is joining the FDA in challenging the approval package, with both agencies pointing to incorrect or misleading data. The move follows an earlier EMA review launched after questions surfaced about the Advocate study data used to support approval. In the US, the FDA has also proposed withdrawal, setting the stage for additional process, including a hearing. For biotech companies, the Tavneos case underscores how regulatory decisions can rapidly unwind when sponsors can’t rely on the evidence trail, particularly around trial data provenance and labeling.