NasdaqGS:MRNABiotechs
FDA Reopens Review Of Moderna Flu Shot And Shifts Investor Focus
The U.S. FDA is now reviewing Moderna’s mRNA flu vaccine application after previously issuing a Refusal to File tied to the study’s choice of comparator.
This reversal reopens the regulatory path for Moderna’s mRNA flu program, which is part of the company’s broader respiratory vaccine portfolio.
The shift follows public criticism of the initial decision and comes at a time when mRNA platforms remain central to Moderna’s long term product plans.
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