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FDA Reverses Course To Review Moderna’s mRNA Flu Shot Under Split Pathway

The reversal follows a rare refusal-to-file over the trial comparator for seniors, with a decision due August 5.

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

Valneva Pulls U.S. Filings for Chikungunya Vaccine as FDA Halts Trials Over Safety Review

Moderna Scraps CMV Vaccine Program After Phase 3 Failure

FDA Grants Full Approval to Moderna’s Pediatric COVID-19 Vaccine for At-Risk Children

Moderna’s mRNA-1010 Flu Vaccine Outperforms Standard Shot and Advances Toward Approval

FDA Grants Limited Approval to Novavax’s COVID-19 Vaccine