Sobi® (STO: SOBI), today announced a research collaboration involving a new Phase 2a clinical trial for Gamifant® (emapalumab) for the potential treatment of interferon-gamma (IFNγ)-driven sepsis (IDS ...

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 ...

The EMBRACE Phase 2a study will adopt a precision immunotherapy approach for the treatment of sepsis driven by the IDS ...

“Exciting” data were presented on emapalumab in the treatment of refractory macrophage activation syndrome (MAS) in patients with sJIA/Still disease. And the FDA approved three new drugs for JIA.

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

Sobi® (STO: SOBI), today announced a research collaboration involving a new Phase 2a clinical trial for Gamifant® (emapalumab) for the potential treatment of interferon-gamma (IFNγ)-driven sepsis (IDS ...

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 ...

Sobi announces a new research collaboration on the development of Gamifant in sepsis, which is to be presented at the ISICEM congress: Stockholm Thursday, March 20, 2025, 12:00 Hr ...

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

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 ...