CLINICAL
An advisory committee voted 9–7 in favor; agency staff signaled they may go further than the panel.
An FDA advisory committee narrowly voted 9–7 to recommend extending nirsevimab, the long-acting RSV monoclonal antibody, to a defined subgroup of high-risk children up to age 2 — but the divided vote and unusually frank dissent suggest the agency could move further than its panel.
FDA staff said in a briefing memo that the data supported a broader label than the committee endorsed.
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CLINICAL
A two-year study finds that simplifying the order set, not adding alerts, drove the change.
CLINICAL
The drug, a Nav1.8 inhibitor, is the first new mechanism approved for acute pain in two decades.
CLINICAL
An internal evaluation found visit notes shrunk by 38% with no measurable change in clinical accuracy.
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