FDA's vaccine advisory committee unanimously recommended Moderna's mRNA flu vaccine mFlusiva for adults 50 and over, the committee's first new vaccine review since 2023. The FDA expects an approval decision by Aug 5, 2026.
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-based flu vaccine application, with a decision expected by August 5. The company modified its regulatory approach to address concerns about older adults.
Arcturus Therapeutics will release fourth quarter and fiscal year 2025 financial results after market close on March 3, 2026, followed by a conference call at 4:30 p.m. Eastern Time.
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.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
