The FDA issued a complete response letter to Pharming, rejecting the company’s application to expand Joenja’s approval into younger pediatric patients for a rare immunodeficiency indication. The agency’s CRL halts Pharming’s label‑extension plans and requires the company to address outstanding clinical or data‑quality concerns before resubmission. Pharming said the CRL affects its strategy to broaden age indications and that it will engage with regulators to define next steps and data needs.