Your Article Summary
See Latest ArticlesMedImmune Receives FDA Complete Response Letter on Motavizumab
PharmiWeb, 12/03/08
AstraZeneca announced that MedImmune, its wholly owned biologics business, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information on motavizumab. The CRL is in connection with the Biologics License Application (BLA) for motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease, which was submitted on 30 January 2008. Motavizumab is an investigational monoclonal antibody (MAb).
Today in Drug/Product Approvals...keeping you current
Receive free subspecialty "5-minute updates" via email
Recombinant Human Erythropoietin, Epogin Injection
Application for Approval of Additional Indication of Chemotherapy-Induced Anemia
Chugai Pharmaceutical Co., 12/08/09
Synthon announces European approvals for Raloxifene
Synthon, 12/08/09
US FDA approves SEROQUEL for the pediatric treatment of schizophrenia and bipolar mania
AstraZeneca, 12/07/09