Tuesday morning saw the FDA acceptance of a supplemental New Drug Application (sNDA) and supplemental Biologics License Application (sBLA) for three industry powerhouses.
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Merck scored another big win Wednesday with a U.S. Food and Drug Administration approval for an expanded indication of Vaxneuvance, its pneumococcal 15-valent conjugate vaccine. The new indication includes children 6 weeks through 17 years of age.
The U.S. Food and Drug Administration has a handful of PDUFA dates over the next two weeks.