Thursday 30 August 2012

FDA Approves Approval Process

The FDA have approved the approval process to approve Zytiga. The FDA have announced that they have approved priority review status for the approval application to approve Zytiga for prostate patients that have relapsed on androgen deprivation therapy but not yet received chemotherapy. The priority review status means that the application for approval will be processed in 6 months, as opposed to the usual 12 months that this process normally takes.

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