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FDA

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FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

The agency said the Phase 3 control for seniors did not reflect the U.S. best standard of care, a rare procedural rebuke that Moderna disputes.

FDA Refuses to File Moderna’s mRNA Flu Vaccine Application Over Trial Comparator

FDA Backs Leucovorin for Cerebral Folate Deficiency as White House Promotes Autism Use