FDA warns an API supplier about residue on walls, a corroded product line, and open-toed sandals The agency made a point of including photos of the unsanitary conditions in a letter to the company

https://www.statnews.com/pharmalot/2026/09/08/fda-warns-api-supplier-residue-corroded-production-line-sandals/ By Ed SilvermanSept. 8, 2026 Pharmalot Columnist, Senior Writer

A breakthrough pancreatic cancer drug won approval. They still struggle to access it Patients who had hoped to get expanded access have found themselves in a maddening limbo

https://www.statnews.com/2026/09/08/pancreatic-cancer-patients-caught-beween-fda-drug-approval-insurance-coverage/ By Angus ChenSept. 8, 2026 Cancer Reporter

Leukemia drug data suggested a different way to treat diabetes. A new biotech will test that idea Kura Oncology turns experimental therapy into new biotech, Caspian Therapeutics

https://www.statnews.com/2026/09/09/kura-oncology-spins-off-diabetes-focused-caspian-therapeutics/ By Jonathan WosenSept. 9, 2026 West Coast Biotech & Life Sciences Reporter

AMA CEO: AI won’t replace doctors — it will work alongside them AI can master medical tasks. Practicing medicine is much more than that

https://www.statnews.com/2026/09/09/ai-medicine-doctors-replacement-debate-ama-ceo/ By John WhyteSept. 9, 2026 Whyte is CEO of the American Medical Association.

Autonomous AI will beat AI-assisted physicians at some medical tasks by 2030 AI won’t take over doctors’ jobs completely, but it is far more capable than skeptics think

https://www.statnews.com/2026/09/09/ai-medicine-assisted-physicians-research-autonomy/ By Ezekiel J. Emanuel and Abe Baker-ButlerSept. 9, 2026 Emanuel is vice provost for global initiatives and co-director of the Healthcare Transformation Institute at the Perelman School of Medicine and the Wharton School at the University of Pennsylvania. Baker-Butler is a research fellow in the Department of Medical Ethics and Health Policy at the University of Pennsylvania.

Can AI fix health care? In the chaos of emergency rooms, the technology comes up short Ambient scribes, the most advanced AI currently in the ER, haven’t changed the status quo

https://www.statnews.com/2026/09/09/ai-healthcare-limitations-emergency-room-study-medical-scribe-impact/ By Brittany TrangSept. 9, 2026 Health Tech Reporter

FDA names acting heads of drug and vaccine centers to permanent roles Agency taps Jared Seehafer for new role focused on AI By Margaret MantoSept. 8, 2026 Washington Correspondent

https://www.statnews.com/2026/09/08/fda-names-leaders-cder-cber-michael-davis-karim-mikhail/?utm_campaign=the_readout&utm_medium=email&_hsenc=p2ANqtz-8kKHt7MCJ7gsb3nj7mRAys9T8RNZV51rdJSI5UvaA0LazPQhn4YuCF0tYcVXOIXZ6iDBovN8eDvzJLwDoDND6Q4wcz4Q&_hsmi=438127268&utm_content=438127268&utm_source=hs_email