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FDA Grants Priority Review to Merck’s New BLA for Adult Pneumococcal Conjugate Vaccine

Dec 19, 2023

Merck announced that the US FDA has accepted for priority review its new Biologics License Application (BLA) for V116, its investigational 21-valent pneumococcal conjugate vaccine for invasive pneumococcal disease and pneumococcal pneumonia in adults.  The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of 17 June 2024.