Uplizna
FDA broadens label for Amgen’s Uplizna as it enters rare disease competition
Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing
Japan Approves Anti-CD19 Monoclonal Antibody UPLIZNA for Suppression of Relapse in Immunoglobulin G4-Related Disease (IgG4-RD)
UPLIZNA; Inebilizumab; Anti-CD19 monoclonal antibody; IgG4-related disease (IgG4-RD); Immunoglobulin G4; Japan approval; Relapse suppression; MITIGATE trial; Mitsubishi Tanabe Pharma; Ministry of Health, Labour and Welfare
New Uplizna data drop in myasthenia gravis, while clock ticks on IgG4 decision
Uplizna, Myasthenia Gravis, Effectiveness, Improvement
Amgen’s Uplizna Achieves Phase 3 Success in Treating Immunoglobulin G4-Related Disease, Paving Way for Label Expansion
Amgen, Uplizna, Phase 3, Immunoglobulin G4-Related Disease, IgG4-RD, Rare Autoimmune Disease, Label Expansion
Amgen’s Uplizna Achieves Success in Phase 3 Trial for Immunoglobulin G4-Related Disease (IgG4-RD)
Amgen, Uplizna, IgG4-RD, Phase 3 Trial, Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD)