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See Latest ArticlesFDA Advisory Committee Recommends Randomized Trial to Support Proposed Indication for Clolar in Adult AML
Genzyme, 09/02/09
Genzyme Corporation announced that the FDA's Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar in adult myeloid leukemia. The committee found that the single–arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar's efficacy and safety in the proposed patient population.
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Today in Drug Trials...keeping you current
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A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimers disease: a post hoc analysis
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