Vivacta Bio and Grit Bio have secured FDA orphan drug designation for GT801 in autoimmune hemolytic anemia. Early findings from two patients showed complete responses following treatment with the investigational in vivo CAR-T therapy, which uses targeted lipid nanoparticles to generate CD19-directed immune cells inside the body.
Hinge Bio, Inc. doses first subjects in HB2198 Phase 1 trial. Discover what this could mean for lupus treatment and next-generation immune reset therapies.
Amgen has received approval from the United States Food and Drug Administration for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. The greenlight makes Uplizna the first and only CD19-targeted B cell therapy approved for this patient population, introducing a twice-yearly dosing regimen