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Diabetes drug soothes brain inflammation in female mice with MS (Fierce Pharma)
Medtech
Medical device maker Becton Dickinson's CFO to depart; shares slide (Reuters)
Lyra launches ‘clinical-grade’ chatbot amid growing concern about mental health and AI (STAT)
Thiel, Bezos Back Startup Treating Tumors With Sound Waves (Bloomberg)
How wearable maker Whoop is making its move into healthcare (Endpoints)
Town Hall Ventures raises $440M fund as it invests deeper into health tech (Endpoints)
BD CFO Chris DelOrefice leaving for new job (MedTech Dive)
Abbott CEO: ‘We’re right on time’ to the PFA party (MedTech Dive)
Food & Nutrition
In Texas, ex-vegan restaurateurs put MAHA’s vision for farming to the test (STAT)
Food recalls are on the rise. What happens to the waste? (Food Dive)
Government, Regulatory & Legal
The Health-Care Debate That’s Driving the Shutdown (Again) (Bloomberg)
‘Doctor Mike,’ the popular YouTube creator, faults AMA communication strategies to counter misinformation (STAT)
Democratic governors form a public health alliance in rebuke of Trump administration (STAT)
Doctor groups need to ‘step up to the plate’ as CDC guidance becomes harder to trust, former leaders say (STAT)
Medicare backs off plan to pause doctor payments amid shutdown (STAT)
Idaho First to Pull Back the Curtain on Health Insurance Pain (Bloomberg)
Court blocks Cosette's attempt to drop $438 million Mayne deal; shares jump (Reuters)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
Three major pharmaceutical industry groups—two in the US and one in India—have called for changes to the US Food and Drug Administration's (FDA) Scale-Up and Post-Approval Changes (SUPAC) guidelines. They believe these guidelines should be updated to reflect more modern manufacturing methods and better align with International Council for Harmonisation (ICH) standards.
Patients with breast cancer said faster approval times for oncology products, as a trade-off for evidentiary certainty, is most permissible in situations where there are no treatment alternatives, the results from a recent qualitative study suggest.