Breaking News, Trials & Filings

U.S. FDA to Initiate Review of Moderna’s Investigational mRNA Flu Vax

Following a prior Refusal-to-File and Type A meeting, the FDA's CBER will proceed to review BLA for mRNA-1010.

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By: Kristin Brooks

Managing Editor, Contract Pharma

mRNA vaccine

Moderna, Inc. announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. FDA in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additiona...

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