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Merck Seeks New Indications for Gardasil

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Merck has submitted a sBLA for Gardasil to the FDA to update the labeling to include efficacy data showing protection against additional cervical cancer causing HPV types responsible for more than 10% of cervical cancers, vaginal and vulvar, and data on immune memory. Gardasil is approved for use in girls and women ages 9 to 26 for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaI...

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