Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia.
Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the rst-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA) ...Currently no FDA-approved therapies are ...
Food and Drug Administration (FDA) has approved the extension of the current VUEWAY® (gadopiclenol) solution for injection, intravenous use, for use in neonates and infants ... https.//www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2022.