Merck's pneumococcal vaccine suffers PDUFA delay in pediatric population, with Pfizer hot on its tail
Back in July, Merck’s pneumococcal vaccine Vaxneuvance got the seal of approval from the FDA to treat adults, with analysts predicting it could be a blockbuster product and secure more than $1 billion in peak sales. A few months later in December, the FDA granted Priority Review for an sBLA for Vaxneuvance to be potentially indicated for minors and infants.
And the federal agency gave the big pharma a PDUFA date of April 1, 2022. But rather than come to a decision Friday, the FDA instead pushed out the PDUFA date by three months to July 1.
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