The FDA has extended the Prescription Drug User Fee Act (PDUFA) date of the supplemental marketing application for Merck & Co Inc's MRK pneumococcal 15-valent conjugate vaccine in infants and children to July 1, 2022.
- The FDA requested additional data analyses from the pediatric studies, which Merck has submitted to the FDA. The FDA has asked for no new studies.
- Also See: Related: Merck's Next-Gen Pneumococcal Conjugate Vaccine Shows Efficacy In Pediatric Trials.
- In December 2021, the FDA granted priority review for the Company's application for VAXNEUVANCE to prevent invasive pneumococcal disease in children 6 weeks through 17 years of age.
- See here Benzinga's Full FDA Calendar.
- Price Action: MRK shares are up 0.09% at $82.09 during the market session on the last check Friday.
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