The U.S. Food and Drug Administration (FDA) has accepted Sobi’s supplemental Biologics License Application (sBLA) for Gamifant (emapalumab-Izsg) for use in adult and paediatric patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still’s disease with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. The application was granted Priority Review with a PDUFA date of June 27, 2025. “HLH/MAS in Still’s disea...