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Liraglutide Cancer Signal Puts Agency In Uncharted Review Territory

Executive Summary

Approving Novo Nordisk's Victoza (liraglutide) for type 2 diabetes would require FDA to surmount a substantial hurdle in the thyroid cancer signal seen with the GLP-1 analog

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FDA Clears Victoza, But Warnings And More Studies Pose Hurdles

That FDA's approval of Novo Nordisk's Victoza (liraglutide) uses its full cadre of FDA Amendments Act-granted drug safety controls - a Risk Evaluation and Mitigation Strategy and mandatory post-marketing requirements - is not surprising, given the concern about a potential cancer risk. But it is a disappointment to investors

FDA Clears Victoza, But Warnings And More Studies Pose Hurdles

That FDA's approval of Novo Nordisk's Victoza (liraglutide) uses its full cadre of FDA Amendments Act-granted drug safety controls - a Risk Evaluation and Mitigation Strategy and mandatory post-marketing requirements - is not surprising, given the concern about a potential cancer risk. But it is a disappointment to investors

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