How does FDA recommend using Bayesian Statistics to inform Regulatory Decisionmaking around clinical trials?

FDA’s January 2026 draft guidance on Bayesian methodology in drug and biologics trials signals a clear willingness to see Bayesian methods used for regulatory decisionmaking around clinical trials. The guidance lays out how sponsors (i.e., pharmaceutical manufacturers) should pre-specify priors, success criteria, and simulations so that Bayesian designs remain interpretable, control error rates when needed,…

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Digital Health’s Latest Unicorn: Why Investors Are Backing Midi’s Model for Women’s Health

Virtual women’s health provider Midi Health has reached unicorn status after raising a $100 million Series D, with investors backing its insurance-covered, direct-to-consumer model. The company is positioning itself as a long-term, virtual “hospital without walls” designed to meet women’s health needs across midlife and beyond. The post Digital Health’s Latest Unicorn: Why Investors Are…

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When the Doctor Needs a Checkup

He was a surgical oncologist at a hospital in a Southern city, a 78-year-old whose colleagues had begun noticing troubling behavior in the operating room. During procedures, he seemed “hesitant, not sure of how to go on to the next step without being prompted” by assistants, said Mark Katlic, director of the Aging Surgeon Program…

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