Hemophagocytic Lymphohistiocytosis

• FDA approval · 2026-03-17
  FDA Approved: GAMIFANT — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

  FDA approved a supplemental application for GAMIFANT (emapalumab-lzsg) submitted by Swedish Orphan Biovitrum AB (publ).

• FDA approval · 2025-06-27
  FDA Approved: GAMIFANT — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

  The FDA approved a supplemental application for GAMIFANT (emapalumab-lzsg) filed by Swedish Orphan Biovitrum AB (publ). The action updates t…

• FDA approval · 2020-06-26
  FDA Approved: GAMIFANT — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

  FDA approved a supplemental application for GAMIFANT (emapalumab-lzsg) from Swedish Orphan Biovitrum AB (publ), updating its labeling/indica…

• FDA approval · 2018-11-20
  FDA Approved: GAMIFANT — Original Application (Swedish Orphan Biovitrum AB (publ))

  FDA approved GAMIFANT (emapalumab-lzsg) in an original application for the treatment of primary hemophagocytic lymphohistiocytosis. It repre…