Moderna (MRNA) Issues Update on Investigational RSV Vaccine

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Go back to Moderna (MRNA) Issues Update on Investigational RSV Vaccine

Moderna Announces Update on Investigational RSV Vaccine

May 10, 2024 7:03 AM EDT

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... More