The FDA extended its decision deadline by three months for Agios Pharmaceuticals’ drug Pyrukynd, a treatment candidate for thalassemia, to allow for additional review of a liver safety mitigation plan. The new target date for approval is December 7. This delay reflects regulatory caution in balancing therapy access for thalassemia—an inherited blood disorder—with concerns about potential liver toxicities. The agency continues its thorough evaluation process to ensure patient safety.