THE TRUMP ADMINISTRATION +++++

THE TRUMP ADMINISTRATION Politico: Makary’s Time Atop FDA Over, Diamantas Named Acting Commissioner https://www.politico.com/news/2026/05/12/makary-fda-resign-white-house-00916014?utm_campaign=KHN:+First+Edition&utm_medium=email&_hsenc=p2ANqtz--f29gvpS63WbbMBe5tTKEIMCuBx8BwQ4OoS-oFohhkxR3C3epGCBmyyPTEeg2TYrI3mCzw57_ZYQhAgOOKyVowoch-Lg&_hsmi=418557843&utm_content=418557843&utm_source=hs_email Marty Makary’s nine lives atop his agency are over. The embattled Food and Drug Administration commissioner is resigning from his role Tuesday after 13 months leading the federal agency, according to an administration official granted anonymity to discuss the development. Kyle Diamantas, who previously worked as the top food official at the agency, will lead the FDA in an acting capacity, the administration official said. (Lim and Gardner, 5/12) AP: Trump’s FDA Chief Is Out After Angering Pharma CEOs, Vaping Lobbyists And Anti-Abortion Activists https://apnews.com/article/fda-trump-makary-kennedy-vaccines-drugs-ef151784342c48cca3b91a829d615b5e?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9xxX3tozTcI8V2nckDoi-P79eoyQMr_ovbqzRyscnppze4kQUz7ZPC9DwAu1b2U7p8Rh4aGpQS28ewsB-w0knF39lDaQ&_hsmi=418557843&utm_content=418557843&utm_source=hs_email The head of the Food and Drug Administration, Dr. Marty Makary, is resigning after a rocky tenure that drew months of complaints from health industry executives, anti-abortion activists, vaping lobbyists and other allies of President Donald Trump. News of Makary’s departure Tuesday came just 13 months after he was confirmed to lead the powerful regulatory agency. (Perrone and Min Kim, 5/13) The 19th: FDA Commissioner Marty Makary's Exit Could Threaten Abortion Access https://apnews.com/article/fda-trump-makary-kennedy-vaccines-drugs-ef151784342c48cca3b91a829d615b5e?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9xxX3tozTcI8V2nckDoi-P79eoyQMr_ovbqzRyscnppze4kQUz7ZPC9DwAu1b2U7p8Rh4aGpQS28ewsB-w0knF39lDaQ&_hsmi=418557843&utm_content=418557843&utm_source=hs_email Food and Drug Commissioner Marty Makary’s planned resignation creates a new opening for anti-abortion activists to push for national restrictions on the procedure — and in particular, limit the availability of a key abortion drug. The move comes as anti-abortion groups became angry over what they viewed as his agency’s failure to curb access to the drug. (Luthra and Rodriguez, 5/12) Fox News: FDA Approves First Non-Antipsychotic Drug For Alzheimer's Agitation https://www.foxnews.com/health/new-option-available-alzheimers-patients-fda-approves-expanded-drug-use?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz--c3kMM0F4Fy72VY1sUmBAqDG7Hr94mUmTlset_PUrSe_XhZID1KFNr0zi49CaVXUz9zBuLG75s6fR-sqQ4ir-xE0Ba3Q&_hsmi=418557843&utm_content=418557843&utm_source=hs_email The U.S. Food and Drug Administration has green-lit the first-ever non-antipsychotic drug treatment for agitation in Alzheimer’s disease patients. The drug, Auvelity, was originally FDA-approved in 2022 for treating adults with major depressive disorder. Most recently, its use has been expanded for agitation associated with dementia. Agitation is a common and "distressing" symptom in adults with Alzheimer’s, according to the agency. The condition is characterized by excessive motor activity, or verbal or physical aggression. (Stabile, 5/12) CIDRAP: FDA Clears First AI-Based Early Warning System For Sepsis https://www.cidrap.umn.edu/sepsis/fda-clears-first-ai-based-early-warning-system-sepsis?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsenc=p2ANqtz-9TaXkVwzRRUHNYCZecz4Fzul6ZQ0BEvYfwz7zPhUIj3ddTVWIB1VM386Ij47qFFvy2eUTbqITsh8_P8vZ2KPLD4skVBQ&_hsmi=418557843&utm_content=418557843&utm_source=hs_email The Food and Drug Administration (FDA) has cleared an artificial intelligence (AI)-based sepsis detection system for approval. The Targeted Real-Time Early Warning System, developed by researchers at Johns Hopkins University and commercialized by Bayesian Health, integrates electronic health records with advanced clinical AI to continuously monitor patients and flag sepsis up to 48 hours before a clinician suspects it. A 2022 study of more than 764,000 patient encounters at five US hospitals found that when clinicians acted on the tool’s alerts, sepsis patients were 18% less likely to die in the hospital. (Dall, 5/12)