The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant (emapalumab-Izsg) for haemophagocytic lymphohistiocytosis (HLH)/macrophage activation ...

Sobi® (STO: SOBI), today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) ...

HLH/MAS in Still's disease is a serious and potentially fatal complication where patients can experience intense hyperinflammation and even multiple organ failure, said Lydia Abad-Franch, MD, MBA, ...

US FDA grants priority review to Sobi’s sBLA for Gamifant for use in adult and paediatric patients with HLH/MAS in Still’s disease: Stockholm Friday, February 28, 2025, 09:00 ...

STOCKHOLM, Feb. 27, 2025 /PRNewswire/ -- Sobi® (STO: SOBI), today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for ...

"There is no approved therapy for HLH/MAS today. Gamifant® (emapalumab-Izsg) selectively neutralizes interferon gamma (IFN-γ), a key driver of hyperinflammation, and if approved, may also help ...

Emapalumab-Izsg is under the FDA’s Priority Review for hemophagocytic lymphohistiocytosis/macrophage activation syndrome in Still disease.