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Cell Therapeutics, today announced that the Office of New Drugs of the U.S. Food and Drug Administration after carefully reviewing the materials CTI submitted in support of its appeal, the reviews of the New Drug Application for pixantrone prepared by the FDA staff, the transcript of the March 22, 2010 Oncology Drugs Advisory Committee meeting and consulting with the Center for Drug Evaluation and Research's Deputy Director of Clinical Science and the Office of Biostatistics, concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial, provided two key matters can be satisfactorily resolved.
Scientists are reporting that variants of a drug already approved for treating multiple sclerosis show promise as a long sought treatment for victims of bioterrorist attack with botulinum neurotoxin which is 10,000 times deadlier than cyanide and the most poisonous substance known to man.
A team of researchers at the Wake Forest Baptist Medical Center found that information found on the internet can serve as good means to diagnose individuals who suspect they have a rare disorder that has not been identified by their doctors.
Mount Sinai Hospital researchers including Drs. Andras Nagy and Jeff Wrana have discovered new insights into the genesis of stem cells, which will improve the efficiency of stem cell creation for use in tissue regeneration and in the development of new drugs.
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