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FDA’s January 2026 draft guidance on Bayesian methodology in drug and biologics trials signals a clear willingness to see Bayesian methods used for regulatory decisionmaking around clinical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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