The FDA approved Moderna’s mRNA influenza vaccine mFlusiva (mRNA-1010), marking the first U.S. seasonal flu vaccine built on mRNA technology. The approval covers adults 50–64 and adults 65 and older, with the 65+ clearance on an accelerated pathway pending additional postmarketing data. Moderna’s mFlusiva approval follows a reversal after the FDA initially declined to review the application earlier this year, then reversed course after meeting with the company. The program is expected to generate confirmatory evidence across two flu seasons. On the infectious disease diagnostics side, Co-Diagnostics filed a 510(k) premarket notification with the FDA for a point-of-care multiplex upper respiratory infection test. The PCR panel is designed to differentiate influenza A/B, COVID-19, and RSV using nasal swabs and includes a CLIA waiver request to support decentralized testing.