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Merck Gardasil gets priority

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's action date for Merck's human papillomavirus vaccine Gardasil is June 8 following the agency's priority review designation, announced Feb. 7. Merck adds that "since submission to the FDA in December, Merck has also submitted applications for Gardasil to additional regulatory agencies including those in the European Union and Australia, Mexico, Brazil, Argentina, Taiwan and Singapore." GlaxoSmithKline recently said it plans to file a BLA for its HPV vaccine Cervarix by year-end...

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