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Feb 19, 2026
The FDA announced it will generally require only one pivotal trial for drug approvals, ending the decades-old two-trial standard. The policy aims to reduce development costs and speed market access while maintaining focus on trial quality.
Feb 19, 2026
The FDA will host Rare Disease Day 2026 on February 23, focusing on patient engagement and accelerating treatment development. The agency released its 2026 Strategic Agenda for the Rare Disease Hub, outlining new regulatory pathways and coordination efforts.
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 16, 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.
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 13, 2026
The FDA will review Moderna's mRNA-1010 seasonal influenza vaccine after the company proposed a revised regulatory pathway, setting an August 2026 decision date following an earlier refusal-to-file letter.
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.
