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Merck Looks To Mid-June FDA Decision On Expanded Use Of Gardasil To Older Women

This article was originally published in The Pink Sheet Daily

Executive Summary

Company unveils data at European conference supporting use in women ages 27 through 45; data was sent to FDA late last year.

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

FDA rejects broader indication for the HPV vaccine and revises labeling to include information about a lack of demonstrated efficacy in women older than 26.

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

FDA rejects broader indication for the HPV vaccine and revises labeling to include information about a lack of demonstrated efficacy in women older than 26.

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

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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