Trials & Filings

Bayer Gains Xofigo Approval in EC

Radio-treatment approved in U.S. in May 2013

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Bayer HealthCare has gained marketing authorization from the European Commission for Xofigo (radium Ra 223 dichloride) solution for injection for the treatment of adults with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastases. This decision follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in September of this year. Xofigo was approved by the FDA in May 2013 for the treatment of patien...

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