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September 25, 2025
by Jason Scott

Recon: RFK Jr. launches review of mifepristone; FDA approves Lilly’s advanced breast cancer drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • US FDA approves Eli Lilly's therapy for advanced breast cancer (Reuters)
  • From an elixir for ‘little hotheads’ to deadly overdoses, how Tylenol became a medicinal scapegoat (STAT)
  • Bristol Myers to sell psoriasis drug at over 80% discount to some US patients (Reuters)
  • RFK Jr. Mulls Adding Autism Symptoms to Vaccine Injury Program (Bloomberg)
  • Attorneys urge court overseeing Tylenol autism lawsuits to consider Trump administration's stance (Reuters)
  • Obama rebukes Trump’s Tylenol claims: ‘Violence against the truth’ (The Hill)
  • Thune ‘very concerned’ about Trump, RFK Jr. Tylenol, autism claims (The Hill)
  • RFK Jr. Opens Investigation Into the Safety of the Abortion Pill (Bloomberg)
  • MCED Act Advances In US House Committees, Exact Sciences Cancerguard Poised To Benefit (MedTech Insight)
In Focus: International                                                                                                       
  • UK govt reveals £50M R&D fund as it attempts to assuage drugmakers’ concerns (Endpoints)
  • Merck KGaA CEO Belén Garijo to leave next May, when electronics unit leader will take the helm (Endpoints)
  • Blackstone, Warburg Said to Vie for CVC-Backed Sebia Stake (Bloomberg)
  • Medtronic expands AI, robotics hub in London; Virtuoso robot gets FDA breakthrough status (MedTech Dive)
  • MedTech Industry Makes Case For Smarter Governance To Avoid EU Regulatory Bottlenecks (MedTech Insight)
Pharma & Biotech
  • Moderna crowns new UK facility as other drugmakers pile on the kingdom (Fierce Pharma)
  • Uniqure and its Huntington’s therapy win the week in biotech (STAT)
  • Acadia Pharmaceuticals drug for rare genetic condition fails late-stage study (STAT)
  • Eli Lilly halts trial testing experimental muscle-preserving drug with Zepbound (Reuters)
  • Pfizer's Metsera deal could spark more M&A for pharmas 'tiptoeing into obesity' (Endpoints)
  • Can a virtual team of researchers break a 40-year logjam in this rare cancer? (Endpoints)
  • Catalent moves into new HQ; Fujifilm opens factory in North Carolina (Endpoints)
  • Thyme Care hits $1B valuation in latest funding round (Endpoints)
  • PepGen seeks funds on the back of early-stage data in muscle wasting disease (Endpoints)
  • Hansa’s kidney transplant drug succeeds in Phase 3 trial in US (Endpoints)
  • Why Lower Doses of Cancer Drugs Remain Elusive (Bloomberg)
  • Pharma Is Pushing $200,000 Cancer Drugs When Cheaper Doses May Work (Bloomberg)
Medtech
  • Inside NYU’s AI-powered plan to catch osteoporosis with repurposed CT scans (STAT)
  • US medtech stocks fall as Trump administration opens import probe (Reuters)
  • Epic embraces the newfound attention of its AI tools (Endpoints)
  • US Eyes Robotics, Medical Gear in Latest Tariff Probes (Bloomberg)
  • Que Dallara on Medtronic’s diabetes spinoff, pipeline and Abbott partnership (MedTech Dive)
  • Stryker CEO Lobo: Partnership With Growth Market India Goes Deeper With Second Local R&D Center (MedTech Insight)
  • Backed By $29M, Sunrise Automates Workflow Using AI To Scale Sleep Care Across US (MedTech Insight)
Food & Nutrition
  • From hamburger stand to $1B beverage brand: A look inside Milo’s sweet tea empire (Food Dive)
  • New FDA programs designed to enhance transparency of outbreak investigations (Food Safety News)
Government, Regulatory & Legal  
  • US health agency has sent drug pricing pilot to the White House (Reuters)
  • Anthony Letai of Dana-Farber is front-runner to lead National Cancer Institute (STAT)
  • House Democrat introduces articles of impeachment against RFK Jr. (The Hill)
  • Democrats bet the House on health care (The Hill)
  • California’s Novel Approach to Controlled Substance Inventory and Loss Reporting (FDA Law Blog
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.
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