A Prescription Drug User Fee Act target date of June 27, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics ...

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

Switzerland’s Novimmune has filed its rare disease drug emapalumab in Europe, days after it sealed a deal selling rights to Sweden’s Sobi. The biotech, based in Geneva and Basel, has filed 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 ...

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 ...

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, ...