FDA Extends Action Date for Additional sBLA in Ipilimumab-Re

FDA Extends Action Date for Additional sBLA in Ipilimumab-Refractory Advanced Melanoma

The FINANCIAL -- Merck, known as MSD outside the United States and Canada, on August 18 announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. The FINANCIAL -- Merck, known as MSD outside the United States and Canada, on August 18 announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every » The FINANCIAL Pharmacy

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United States , Canada , American , Rogerm Perlmutter , , Merck Research Laboratories , Drug Administration , American Associated For Cancer Research , Biologics License Application , Priority Review , Merck Research , Cancer Research , Annual Meeting , New England Journal , Pharmacy ,

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