‘We’re open for business’: FDA’s Peter Marks says agency ready to review novel cancer vaccines despite unknowns

Apr 4th 2024 2:27pm EDT

As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns. “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of cancer vaccines […]

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