The Readout Loud 389: Hims' Super Bowl fallout, and the FDA reverses course
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Feb 19, 2026 Katie Palmer, STAT health reporter covering telehealth and regulation. She walks through Hims & Hers’ launch of a compounded GLP-1 pill and the regulatory uproar after a high-profile ad. They also unpack the FDA’s sudden change on reviewing Moderna’s flu shot and what that means for politics, enforcement, and telehealth companies.
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FDA Changes Course On Moderna Flu Shot
- The FDA initially refused to accept Moderna's flu vaccine filing but then moved to review it through different pathways for different age groups.
- The agency now expects a decision by August 5th after switching to regular and accelerated review routes.
Politics And Factionalism Shaped The Decision
- The Moderna episode exposed internal agency disagreement and possible political pressure shaping regulatory decisions.
- Observers see the reversal as reflecting factional FDA views and external political influence around vaccine messaging.
Psychedelic Trials Show Statistically Significant But Modest Gains
- Compass Pathways reported positive phase 3 results for a psychedelic depression treatment, achieving statistical significance but modest effect sizes.
- The trials used a lower clinical-response cutoff and remission rates so clinicians will weigh these nuances during review and adoption.