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Feb 17, 2026
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially refusing, accepting a split regulatory approach with traditional approval for ages 50-64 and accelerated approval for 65 and older. Decision date set for August 5, 2026.
Feb 16, 2026
The FDA reversed its initial refusal and will now review Moderna's mRNA-based flu vaccine application, seeking full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision targeted for August 5, 2026.
Feb 15, 2026
The FDA agreed to review Moderna's mRNA flu vaccine application after initially rejecting it, reversing course within a week. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and above, with a decision expected by August 5.
Feb 12, 2026
The mRNA therapy market is forecast to grow from USD 13.6 billion in 2025 to USD 70.0 billion by 2035 at a 17.8% CAGR, driven by expanding applications beyond vaccines into oncology, rare diseases, and infectious disease treatments including genital herpes.
Feb 10, 2026
The FDA reversed its refusal to review Moderna's mRNA flu vaccine application after the company amended its submission. The agency will now consider full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision expected by August 5, 2026.
