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This was followed by the Prescription Drug User Fee Act (PDUFA) goal date later this month. Updated December 18, 2020. DISCLOSURE NOTICE: The information contained in this release is as of May 18, 2023. Worldwide, there are an estimated 6. RSV annually in infants less than 12 months of age, with approximately 45,000 dying each year from complications associated with the U. FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the FDA had granted priority review to a biologics license application for RSVpreF for the prevention of MA-LRTD and severe MA-LRTD caused by RSV in infants.

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