rf-fullcolor.png

 

February 2, 2026
by Jason Scott

Recon: FDA rejects Aquestive’s allergy therapy over packaging concerns; Novo’s CagriSema tops Wegovy in Phase 3 diabetes study

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • New rule would force PBMs to disclose drug rebates and other fees (STAT)
  • FDA rejects Aquestive's allergy drug over packaging issues (Endpoints)
  • FDA opens submissions for PreCheck program to speed up US factory builds (Endpoints)
  • Pharming’s immunodeficiency drug gets CRL for use in younger patients (Endpoints)
  • Does America Still Know How to Spur Innovation? (Bloomberg)
  • Top 10 most anticipated drug launches of 2026 (Fierce Pharma)
In Focus: International
  • Sanofi is reprimanded by a U.K. trade group for misleading claims about a Pfizer vaccine (STAT)
  • European law changes mean drugmakers may have to grapple with generic competition sooner (Endpoints)
  • China’s Pampered Cats Spur Weight-Loss Drug Application (Bloomberg)
  • India to Spend $1.1 Billion to Make Biopharma Production Hub (Bloomberg)
  • A Quality Tax for Foreign Drug Makers? The Links Between National Security, Trade Deals, and Drug Quality. (FDA Law Blog)
Pharma & Biotech
  • Novo Nordisk's next-gen obesity drug outperforms Wegovy in late-stage diabetes trial (Reuters)
  • Obesity market sales potential tightens as Novo and Lilly enter new era (Reuters)
  • As male birth control gets closer to reality, men are lining up for clinical trials (STAT)
  • As its immunology work draws attention, Sanofi also pushes forward in rare disease (STAT)
  • GSK gives back rights to Wave Life Sciences' lead RNA editing program (Endpoints)
  • SanegeneBio licenses RNAi candidate to Genentech for $200M upfront (Endpoints)
  • Sanofi’s rare disease drug notches one win, one loss in a pair of Phase 3 trials (Endpoints)
  • Even Tech Skeptics Can Cheer AI’s Promise in Decoding the 'Dark Genome' (Bloomberg)
  • AstraZeneca Shares Start Trading in US After Listing Upgrade (Bloomberg)
Medtech
  • Boosting Your Brain With a Chip Carries a Price (Bloomberg)
  • Lawsuit challenges ethylene oxide exemptions for device sterilizers (MedTech Dive)
  • Grail files for FDA approval of multi-cancer early detection test (MedTech Dive)
  • At INBRAIN’s 5-Year Mark, BCI Experts Confront The Promise, Perils Of Brain-Computer Interfaces (MedTech Insight)
  • Thermo Fisher winds down Boston area plant (Fierce Pharma)
Food & Nutrition
  • France Lowers Limit for Toxin in Baby Formula, May Spark Recalls (Bloomberg)
  • EU body's advice on toxin limit in baby formula prompts more recalls (Reuters)
  • The food and beverage outlook for 2026 (Food Dive)
Government, Regulatory & Legal
  • Nine states challenge federal mandate that disabled people receive care in community (STAT)
  • Newsom files a civil rights complaint against CMS’ Oz in latest feud with the Trump administration (STAT)
  • The EPA just erased a century of public health progress (STAT)
  • How much should psychedelics researchers disclose about their personal use? (STAT
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.