Merck Issues Statement On Potential Reduced Dosing Recommendation For Gardasil 9
ReutersMay 23, 2025 6:06 PM
May 23 (Reuters) - Merck & Co Inc MRK.N:
MERCK STATEMENT ON A POTENTIAL REDUCED DOSING RECOMMENDATION FOR GARDASIL®9
AFFIRMED POSITION REGARDING ALTERNATE DOSING REGIMENS FOR GARDASIL®9 FOR PREVENTION OF CERTAIN HPV-RELATED CANCERS AND DISEASES - WEBSITE
UNTIL THERE ARE SUFFICIENT DATA FOR FDA & EC TO LICENSE OTHER GARDASIL 9 REGIMEN, CDC VIEW SHOULD REMAIN CONSISTENT WITH APPROVED LABELING
SOUGHT GUIDANCE FROM FDA REGARDING ITS PROPOSED SINGLE DOSE TRIAL DESIGNS FOR GARDASIL 9
FDA WAS CLEAR ABOUT "HIGH STANDARD OF EVIDENCE" THAT WOULD BE REQUIRED FOR LICENSURE OF SINGLE DOSE REGIMENS FOR GARDASIL 9
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