FDA Updates Articles
The U.S. Food and Drug Administration has approved Roche’s Actemra (tocilizumab), the first treatment for adult patients with giant cell arteritis.
The U.S. Food and Drug Administration has approved new product strengths for Octapharma’s NUWIQ.
The U.S. Food and Drug Administration has approved Novo Nordisk’s Rebinyn (coagulation factorIX [recombinant], glycopegylated) to treat hemophilia B in adults and children.
The U.S. Food and Drug Administration has approved Renflexis (infliximababda, Samsung Bioepis), the second biosimilar to Remicade (infliximab, Janssen Biotech).
The U.S. Food and Drug Administration has approved Bio Products Laboratory’s Gammaplex 10% (immune globulin intravenous [human] 10% liquid) for the treatment of primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura in adults.
The U.S. Food and Drug Administration approved bezlotoxumab (Zinplava, Merck) to prevent the recurrence of Clostridium difficile (C. diff) infection (CDI) in patients aged 18years and older.
The U.S. Food and Drug Administration has approved Amgen’s Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for the treatment of several autoimmune conditions.
The U.S. Food and Drug Administration has approved Gilead Sciences’ Vemlidy (tenofovir alafenamide,TAF) 25 mg once-daily treatment for adults with chronic hepatitis B virus(HBV) infection with compensated liver disease.
A lung cancer vaccine developed in Cuba has been approved by the U.S. Food and Drug Administration for a clinical trial at Roswell Park Cancer Institute in Buffalo, N.Y.
The U.S. Food and Drug Administration granted orphan drug designation to dusquetide (SGX942, Soligenix) for the treatment of macrophage activation syndrome.
The U.S. Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis) to treat advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.
True North Therapeutics’ TNT009 for the treatment of autoimmune hemolytic anemia, including cold agglutinin disease (CAD), has been granted orphan drug status by the U.S. Food and Drug Administration.
