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"Novo Nordisk is counting on its marriage of Tresiba and Victoza--already approved in the EU as Xultophy--to keep ahead of competition from Sanofi on its way to the blockbuster strata. But before it can get going in the U.S., FDA advisers have concerns to air.", www.fiercepharma.com
"Bagsværd, Denmark, 20 May 2016 - Novo Nordisk announced today that the US Food and Drug Administration (FDA) has published the briefing documents ahead of the 24 May 2016 Advisory Committee meeting to discuss the New Drug Application (NDA) for IDegLi", www.pharmiweb.com
"A preliminary review by the U.S. Food and Drug Administration of Novo Nordisk A/S's experimental diabetes drug, IDegLira, questioned the interpretability of the study findings and practical use of the treatment, according to a review posted on the agency's website on Friday.", uk.reuters.com
"Going into another head-to-head diabetes drug showdown with Sanofi, Novo Nordisk’s regulatory team will need to spend some time next Tuesday explaining to an FDA advisory panel just how it designed a big late-stage program for IDegLira.", www.fiercebiotech.com
"A preliminary review by the U.S. Food and Drug Administration of Novo Nordisk A/S's experimental diabetes drug, IDegLira, questioned the interpretability of the study findings and practical use of the treatment, according to a review posted on the agency's website on Friday.", www.reuters.com
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