Medivation, Inc. (MDVN) said Monday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for enzalutamide, formerly MDV3100.
The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.
The FDA is expected to determine within 60 days whether to accept the filing for review.
Medivation said it has requested Priority Review, a designation given to drugs that offer a significant improvement in treatment or provide treatment where no satisfactory alternative therapy exists.
If a Priority Review is granted, the FDA goal for completing a review is six months.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.