MedImmune Receives FDA Complete Response Letter on Motavizumab
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). [more...]
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