FDA Approves First Drug to Treat Giant Cell Arteritis
The U.S. Food and Drug Administration has approved Roche’s Actemra (tocilizumab), the first treatment for adult patients with giant cell arteritis.
Octapharma USA’s NUWIQ Receives FDA Approval for Expanded Vial Strengths
The U.S. Food and Drug Administration has approved new product strengths for Octapharma’s NUWIQ.
Novo Nordisk’s Rebinyn Approved by FDA to Treat Hemophilia B
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.
FDA Approves Renflexis, Biosimilar to Remicade
The U.S. Food and Drug Administration has approved Renflexis (infliximababda, Samsung Bioepis), the second biosimilar to Remicade (infliximab, Janssen Biotech).
FDA Approves Gammaplex 10% to Treat Adult PI and ITP Patients
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.
Approval Recommended for Zinplava to Prevent Recurrence of C. Diff
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.
FDA Approves Amgen’s Amjevita as a Biosimilar to Humira
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.
FDA Approves Vemlidy to Treat Chronic Hepatitis B Virus Infection
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.
Vaccine for Lung Cancer Approved for Clinical Trial
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.
Dusquetide Granted Orphan Drug Status to Treat Life-Threatening Immune Disorder
The U.S. Food and Drug Administration granted orphan drug designation to dusquetide (SGX942, Soligenix) for the treatment of macrophage activation syndrome.
