GSK gets USFDA priority review for RSV older adult vaccine
GSK’s RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.;
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London: GSK plc has announced that the US Food and Drug Administration (USFDA) has accepted a Biologics License Application (BLA) and granted Priority Review for its respiratory syncytial virus (RSV) older adult vaccine candidate.
The US FDA grants Priority Review to applications for vaccines that, if approved, would offer significant improvements in the safety or effectiveness of the treatment or prevention of serious conditions when compared to standard applications. A Priority Review designation means the US FDA's goal is to expedite the review of a BLA, reducing the review period by four months. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is 3 May 2023.
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