Women's Health Weekly
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Diagnostics
Diagnostics products company submits regulatory information to U.S. FDA for Lymphoseek
January 19th, 2006
Neoprobe Corporation (NEOP) announced that it has submitted results from seven nonclinical studies of Lymphoseek to the U.S. Food & Drug Administration (FDA) which appear to provide an adequate safety profile for Lymphoseek. The studies included genotoxicity studies, an acute toxicity study, repeat dose toxicity studies and a cardiovascular safety pharmacology study. The study results will have to be confirmed by FDA review prior to the commencement of a phase II study in humans to further evaluate the safety and efficacy of Lymphoseek. Neoprobe holds the exclusive rights to Lymphoseek under license from the University of California, San Diego (UCSD)...
Source: Women's Health Weekly (2006-01-19)
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