Amgen’s Prolia approved in the USA but …

On Tuesday, the US Food and Drug Administration (FDA) approved Amgen’s RANK-L inhibitor denosumab (Prolia®) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. However, what they have not done (yet) … READ MORE …

EMEA approves Prolia for marketing in Europe

According to a report from Reuters and a media release on the Amgen web site, the European Medicines Agency (EMEA) has approved denosumab (Prolia®) for marketing in Europe. … 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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