Medicines Articles
New rules issued by the U.S. Department of Health and Human Services give employers more leeway to withhold birth control coverage on religious grounds.
The U.S. Food and Drug Administration has approved Kedrion Biopharma’s and Kamada’s KEDRAB (rabies immune globulin [human]) for passive, transient postexposure prophylaxis of rabies infection.
Novartis’ Kymriah (tisagenlecleucel) has been approved by the U.S. Food and Drug Administration to treat pediatric acute lymphoblastic leukemia.
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.
Sandoz announced the U.S. market introduction of rosuvastatin calcium tablets, a generic version of Crestor by AstraZenica Pharmaceuticals LP.
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.
