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September 15, 2025
by Jason Scott

Recon: FDA takes on DTC ads, going after Hims & Hers; Kennedy appoints 5 new ACIP members

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

In Focus: US
  • Kennedy appoints five new members to US vaccine panel (Reuters)
  • Targeting Hims & Hers, F.D.A. Takes on a New Type of Drug Advertiser (The New York Times)
  • Let the rulemaking begin: Why direct-to-consumer drug ads deserve a closer look (STAT)
  • Marty Makary deems DTC drug advertising 'a public health crisis' (Fierce Pharma)
  • UnitedHealth Is Spending Big on Trump Allies to Fix Its Washington Problems (The Wall Street Journal)
  • The Trump admin’s cruel disbanding of the Pediatric Brain Tumor Consortium (STAT)
In Focus: International                                                                                                       
  • AstraZeneca shares down 3% after rating cut, UK investment pause (Reuters)
  • Novartis signs up to $5.7 billion licensing deal with Monte Rosa Therapeutics (Reuters)
  • WHO backs weight-loss drugs for obesity and urges change in mindset (Reuters)
  • Novo Nordisk’s Diabetes Pill Gets EU Label Extension For Heart Benefits (The Wall Street Journal)
  • BMS sells majority stake in historic US-China pharmaceutical JV (Fierce Pharma)
Pharma & Biotech
  • Colgate to change toothpaste packaging to address Texas AG fluoride concerns (Reuters)
  • aTyr hits record low as lung disease drug fails in late-stage trial (Reuters)
  • Updated: Novartis extends deal spree with $120M for Monte Rosa's immune degraders (Endpoints)
  • Exclusive: Lila Sciences is closing in on $300M+ fundraise at $1B+ valuation, to scale up its bet on autonomous science (Endpoints)
  • Abbott links with Hallmark Channel on 'heartfelt' holiday film (Fierce Pharma)
Medtech
  • FDA will convene an advisory committee to tackle AI mental health device regulation (STAT)
  • Lila Sciences says it has raised $235M to go 'all gas, no brake' on its AI-for-science bet (Endpoints)
  • Foundation models are medtech’s newest trend. But what are they? (MedTech Dive)
  • Intuitive da Vinci 5 updates offer feedback during surgery (MedTech Dive)
  • B. Braun buys True Digital Surgery for microscopy technology (MedTech Dive)
  • Breast Tissue Regeneration: Tensive’s Journey To Restore ‘Wholeness’ For Cancer Survivors (MedTech Insight)
Food & Nutrition
  • The MAHA children’s health report falls short on better pesticide regulation (STAT)
  • Ditching Ultraprocessed Foods Can Be Hard. Here’s Where to Start. (The Wall Street Journal)
Government, Regulatory & Legal  
  • Why Trump’s former surgeon general wants Kennedy removed: ‘an absolute failure of leadership’ (STAT)
  • Inside the hospital ‘war rooms’ bracing for Medicaid cuts (STAT)
  • HHS to have Rensselaer investigate question of autism-vaccine link (STAT)
  • Over half of US healthcare workers plan to switch jobs by next year, survey finds (Reuters)
  • FTC’s New Healthcare Division Chief Is Former Antitrust Prosecutor (MedTech Insight)
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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