FDAer Eyes Improvements In Anticoagulant Trial Design
This article was originally published in Pharmaceutical Approvals Monthly
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Agency staff recommend separate assessment of ischemic and hemorrhagic strokes, and exposure-targeting of therapeutic blood levels; cardio-renal panel endorses Daiichi Sankyo’s Factor Xa inhibitor for atrial fibrillation, but concerns about reduced efficacy in normal renal function patients may result in a competitively disadvantaged label.
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