Tag Archives: Approves

FDA Approves Xembify (immune globulin subcutaneous) for Primary Immunodeficiencies

FDA Approves Xembify (immune globulin subcutaneous) for Primary Immunodeficiencies Print this page Barcelona, July 4, 2019.- Grifols, a leading global producer of plasma-derived medicines, announced today that Xembify, its new 20% subcutaneous immunoglobulin, has been approved by the U.S. Food and Drug Administration (FDA). Xembify is used to treat primary immunodeficiencies. The FDA approval marks… Read More »

FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer

FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer Print this page April 12, 2019 — The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or… Read More »

FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis

FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis Print this page March 29, 2019 — The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically isolated… Read More »