Amgen requests expanded indication for denosumab

As expected (and as previously discussed on this site), Amgen has submitted a supplemental Biologics Licensing Application (sBLA) for denosumab (Xgeva®) for the prevention or the delay of the spread of prostate cancer to bone in men with castrate-resistant prostate cancer (CRPC). … READ MORE …

Amgen files new drug application for denosumab

According to a company media release issued last Friday, Amgen has filed a second new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval of denosumab (a RANK-L inhibitor to be known commercially as Prolia®). … READ MORE …

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