10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of 12 May 2024.

Moderna today announced it has been notified by the US FDA that due to administrative constraints, the agency does not expect to complete its review of the biologics license application for mRNA-1345, Moderna's investigational respiratory syncytial virus vaccine, by the previously communicated Prescription Drug User Fee Act date of 12 May 2024. The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.

Read Moderna press release