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Third Time Is Not A Charm For Merck's Bid To Expand Gardasil Use To Older Women

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA not only has declined to approve Merck's human papillomavirus vaccine Gardasil for use in women ages 27-45, it has added to labeling a statement that the vaccine was not shown effective in preventing more serious HPV-related precancerous cervical lesions or cancer in the pivotal study targeting this age group.

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