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Heartflow prices IPO, aiming to net about $180M (MedTech Dive)
Dexcom Builds Momentum Ahead of 15-Day G7 Launch, Eyes AI and G8 for Growth (MedTech Insight)
J&J MedTech’s Digital Head Pushes for Smarter, Standardized ORs With AI and Open Tech (MedTech Insight)
Food & Nutrition
Beverages become essential to consumer wellness routines: report (Food Dive)
Utz Brands to close facility as part of supply chain transformation (Food Business News)
Government, Regulatory & Legal
State AGs sue Trump, HHS over gender-affirming care restrictions (STAT)
AIDS activists sue HHS to obtain Gilead settlement over patents for HIV prevention pills (STAT)
Representatives of expert groups to be barred from work supporting CDC’s vaccine advisers (STAT)
MAGA influencers take a sudden interest in Medicare Advantage reforms, echoing a dark money group (STAT)
White House has no plan to mandate IVF care, despite campaign pledge (The Washington Post)
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.