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Feb 24, 2026
The FDA reversed its decision to reject Moderna's mRNA influenza vaccine application, accepting it for review one week after an initial refusal-to-file that reportedly involved senior leaders overruling staff advice.
Feb 11, 2026
Obesity contributes to about 1 in every 4 infectious disease deaths in the United States and 1 in 10 globally, according to a major study. People with obesity face 70% higher risk of hospitalization or death from infections, with risk tripling at severe obesity levels.
Feb 19, 2026
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-1010 seasonal influenza vaccine application, setting an August 5, 2026 review deadline after the company proposed a revised regulatory approach based on age groups.
Feb 18, 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.
Feb 17, 2026
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Feb 18, 2026
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
Feb 18, 2026
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.
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 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.
Feb 13, 2026
The FDA mandated febrile seizure warnings for flu vaccines and rejected Moderna's mRNA flu vaccine application, with a political appointee overruling agency staff despite no safety concerns identified.
Feb 13, 2026
California-based Centivax has begun dosing participants in a Phase 1A clinical trial of Centi-Flu 01, a universal influenza vaccine designed to target conserved viral regions across all flu strains. Initial data from approximately 180 participants is expected within the year.
