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New Drug News, In Brief

Executive Summary

FDA approves Abbott’s Humira for ulcerative colitis and Bayer/Onyx’s regorafenib for colorectal cancer, Bristol-Myers Squibb/Pfizer’s Eliquis faces a St. Patrick’s Day user fee date, and an NEJM poll finds the medical community is evenly split over use of Gilead’s Truvada for HIV pre-exposure prophylaxis.

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Three-month user fee extension for Bristol-Myers Squibb and Pfizer’s novel oral anticoagulant apixaban raises questions about whether an advisory committee panel will be convened after all, though the companies say none has been scheduled at this time.

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