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Amgen Provides Update on Status of Prolia Biologics License Application Submitted to the U.S. Food and Drug Administration
Amgen, 10/20/09
Amgen Inc. announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the Biologic License Applications for Prolia in the treatment and prevention of postmenopausal osteoporosis.
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FDA Drug Approval Summary: Bevacizumab (Avastin) as Treatment of Recurrent Glioblastoma Multiforme
The Oncologist, 12/03/09
Ustekinumab (Stelara): First-in-class human monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasis
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Safety concerns slow new drug review and approval processes
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