FDA Updates Articles
Hailed as a major advancement in the fight against skin cancer, the U.S. Food and Drug Administration (FDA) has approved a new immune-based therapy for treating metastatic melanoma.
The U.S. Food and Drug Administration approved the first replacement therapy for hereditary factor X deficiency, coagulation factor X (Coagadex, Bio Products Laboratory), derived from human plasma.
The U.S. Food and DrugAdministration (FDA) approved BioProducts Laboratory’s Gammaplex(immune globulin intravenous [human]5% liquid) for pediatric patients 2 years of age and older who have primary immunodeficiency disease (PI).
The U.S. Food and Drug Administration(FDA) has approved revised product labeling for Wilate (von Willebrand factor/coagulation factorVIII complex [human]) to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease patients.
The U.S. Food and Drug Administration(FDA) has granted exclusivity to Flublok influenza vaccine for a period of 12 years.
Pfizer (a licensee of Gliknik Inc.) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its recombinant intravenous immune globulin (IVIG)-mimetic drug
GL-2045 to treat chronic inflammatory demyelinating polyneuropathy (CIDP).
CSL Behring’s Biologics License Application for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin, rIX-FP, has been accepted for review by the U.S.
The U.S. Food and Drug Administration(FDA) has finalized three guidance documents outlining its expectations for biosimilars.
CSL Behring’s Biologics LicenseApplication for the marketing authorization of its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) has been accepted for review by the U.S.
The U.S. Food and Drug Administration(FDA) has approved Octapharma’s manufacturing facility in Vienna, Austria, for the production of Octagam 10% (immune globulin intravenous [human] 10% [100mg/mL] liquid preparation).
FDA has approved Iroko Pharmaceuticals’ Tivorbex (indomethacin), a low-dose painkiller for adult patients.
The U.S. Food and DrugAdministration has approved obinutuzumab (Gazyva, Genentech)for the treatment of patients with previously untreated chronic lymphocyticleukemia.
