Rheumatology Advisor9d
Emapalumab Gets Priority Review for HLH/MAS in Still Disease
Emapalumab-Izsg is under the FDA’s Priority Review for hemophagocytic lymphohistiocytosis/macrophage activation syndrome in Still disease.
FDA accepts Sobi’s Gamifant application for HLH/MAS treatment
The US Food and Drug Administration has accepted Sobi’s supplemental biologics licence application for Gamifant (emapalumab-Izsg) for haemophagocytic lymphohistiocytosis (HLH)/macrophage activation ...
Pharmabiz16d
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
Swedish Orphan Biovitrum AB (Sobi), a specialised international biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License ...
Pharmaceutical Technology16d
FDA accepts Sobi’s Gamifant application for HLH/MAS treatment
Sobi’s Gamifant was previously approved by the US regulator in 2018. © Swedish Orphan Biovitrum AB. The US Food and Drug Administration has accepted Sobi’s ...
Monthly Prescribing Reference17d
Emapalumab Gets Priority Review for HLH/MAS in Still Disease
The biologic was approved in 2018 under the brand name Gamifant ® for the the treatment of adult and pediatric (newborn and older) patients with primary HLH with refractory, recurrent or ...
Finanznachrichten17d
Swedish Orphan Biovitrum AB: US FDA grants Priority Review to Sobi's supplemental Biologics Licence Application (sBLA) for Gamifant (emapalumab-lzsg)
"There is no approved therapy for HLH/MAS today. Gamifant® (emapalumab-Izsg) selectively neutralizes interferon gamma (IFN-?), a key driver of hyperinflammation, and if approved, may also help ...
Le Lézard17d
US FDA grants Priority Review to Sobi's supplemental Biologics Licence Application (sBLA) for Gamifant® (emapalumab-lzsg)
"There is no approved therapy for HLH/MAS today. Gamifant® (emapalumab-Izsg) selectively neutralizes interferon gamma (IFN-?), a key driver of hyperinflammation, and if approved, may also help ...
US FDA grants Priority Review to Sobi's supplemental Biologics Licence Application (sBLA) for Gamifant® (emapalumab-lzsg)
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, ...