Moderna announces update on investigational rsv vaccine

U.s. fda has informed moderna that due to administrative constraints, the agency will not complete its review of mrna-1345 by the pdufa date of may 12, 2024 agency has indicated it expects to complete the review by end of may cambridge, ma / accesswire / may 10, 2024 / moderna, inc. (nasdaq:mrna) today announced it has been notified by the u.s. food and drug administration (fda) that due to administrative constraints, the agency does not expect to complete its review of the biologics license application (bla) for mrna-1345, moderna's investigational respiratory syncytial virus (rsv) vaccine, by the previously communicated prescription drug user fee act (pdufa) date of may 12, 2024. the fda has informed moderna that it is working to conclude the review by the end of may 2024.
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