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DewDiligence

02/21/23 12:15 PM

#5400 RE: DewDiligence #5061

PFE’s maternal RSV vaccine has Aug 2023 PDUFA—(with_FDA_priority_review):

https://finance.yahoo.com/news/u-fda-accepts-biologics-license-114500315.html

In data reported in Nov 2022, one of two primary endpoints was met, but PFE said this was sufficient for FDA approval (#msg-170339033).

GSK terminated its own program for a maternal RSV vaccine, so PFE will have the only maternal RSV vaccine on the market if this BLA is approved.