Amgen shared a fresh analysis with the FDA supporting continued marketing of Tavneos, the company’s therapy for a rare disease that has become the center of an FDA dispute. The submission, filed Thursday, is intended to address the regulator’s concerns and argue for keeping the drug on the market. The dispute escalation underscores how post-approval evaluations can become pivotal moments for rare-disease assets, where continued access and real-world evidence can influence regulatory outcomes. Amgen’s next steps will hinge on the FDA’s follow-on review and the strength of the independent reevaluation it provided.