Cutting-Edge Pediatric Cancer Therapy Approved by FDA
Novartis’ Kymriah (tisagenlecleucel) has been approved by the U.S. Food and Drug Administration to treat pediatric acute lymphoblastic leukemia.
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.
Opioid Addiction: Is There a Solution?
With staggering growth in the number of people addicted to and dying from opioids, government, the medical community and recovery programs are working to turn the tide.
Sandoz Launches Generic Version of Crestor
Sandoz announced the U.S. market introduction of rosuvastatin calcium tablets, a generic version of Crestor by AstraZenica Pharmaceuticals LP.
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.
