• California: Hims & Hers has launched its first AI agent, Labs AI, to help patients interpret biomarker lab results with personalized health insights. Last November, Hims launched its direct-to-consumer lab testing program for health biomarkers and now offers 130 tests across 10 health areas, including heart health, metabolism, and stress. According to Hims' CMO Patrick Carroll, the new AI agent makes customers' lab results clearer, more useful, and easier to engage with. "The AI companion will educate customers on every lab test that they get back. It is not set up to diagnose," Carroll said. "It's set up to format the information and educate customers and that same information that comes from the AI application goes to our provider so they can match up the messaging, and it gives much cleaner, more interpretable results to our customers using AI." Hims also plans to roll out additional AI care agents in the future. "The same tool-grounded reasoning, layered evaluation, and tracing infrastructure that powers Labs AI is the foundation for everything that comes next," said Mo Elshenawy, Hims' CTO. "This is not a one-off feature — it is a platform for embedding intelligence across the care experience." (Landi, Fierce Healthcare, 5/7)
• Maryland: FDA has issued new guidance for manufacturers collecting postmarketing data on the safety of approved drugs and biologics for pregnancy. The goal of the guidance is to improve understanding of the potential risk to pregnant patients and fetuses. "Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy," said Tracy Beth Hoeg, the agency's top drug regulator. "This guidance provides specific recommendations about how postmarketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified." According to MedPage Today, the guidance addresses three different scenarios — drug exposure prior to pregnancy, drug exposure during pregnancy, and postpartum monitoring — and outlines three different approaches manufacturers can take to evaluate safety — case reports and case series, prospective primary data collection through pregnancy registries, and complementary data sources. However, FDA noted the approaches listed in the guidance "are not intended to imply a hierarchy of evidence from the different study methods." (Frieden, MedPage Today, 5/8)
• Washington: Amazon Pharmacy plans to make Novo Nordisk's Ozempic pill available for home delivery. Ozempic is a GLP-1 medication currently approved to treat type 2 diabetes. Customers will be able to receive the medication either through same-day delivery or pickup within minutes at pharmacy kiosks at select One Medical locations. Same-day delivery will be available in nearly 3,000 cities and towns, with plans to expand to 4,500 by the end of the year. Next-day, two-day, or three-day shipping options will also be available in areas where mail order would generally take between five and 10 days. "Amazon Pharmacy continues to provide customers expanded selection and reliable, convenient access to the latest treatments like the Ozempic pill for type 2 diabetes, helping reduce the friction that comes with accessing breakthrough medications," said Tanvi Patel, VP and general manager of Amazon Pharmacy. "With 24/7 access to licensed pharmacists, same-Day and next-day delivery and caregiver support for loved ones managing chronic conditions, we are making it easy for customers to get the medication they need to stay healthy." (Minemyer, Fierce Healthcare, 5/7)

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