Merck Receives Complete Response Letter from the US FDA for Supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab) Six-Week Dosing Schedule
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KENILWORTH, N.J.
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s supplemental Biologics License Applications (sBLAs) seeking to update the dosing frequency for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, to include a 400 mg dose infused over 30 minutes every-six-weeks (Q6W) option in multiple indications.
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