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March 19, 2026
by Jason Scott

Recon: Novo’s Wegovy nabs FDA approval for higher dose under CNPV program; FDA authorizes J&J’s oral psoriasis drug

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • National survey of NIH-funded researchers shows precarious state of U.S. science — ‘This is like the Titanic’ (STAT)
  • US FDA approves higher dose of Wegovy (Reuters)
  • Senate Democrats lay out plans to overhaul health insurance after setbacks under Trump (STAT)
  • There is a successor to 340B lurking on the horizon (STAT)
  • As Trump administration cracks down on health care fraud, people with disabilities feel singled out (STAT)
  • Four major drugmakers will face revived case over 340B prices (Endpoints)
In Focus: International
  • AstraZeneca deepens UK-China ties with cell therapy R&D hub, manufacturing plans (Endpoints)
  • House lawmakers signal willingness to counter China’s biotech gains (Endpoints)
  • UK health official says too soon to declare Kent meningitis outbreak contained (Reuters)
  • Amplifon Buys GN Hearing For €2.3Bn, Taking Aim At Sonova And Demant (MedTech Insight)
  • Injuries, Death, Linked To Intuitive Surgical Stapler Used With Da Vinci Robotic System (MedTech Insight)
Pharma & Biotech
  • Eli Lilly’s ‘triple-G’ drug leads to significant blood sugar, weight reductions in diabetes trial (STAT)
  • Clearing tumors in mice, Azalea Therapeutics advances dream of in vivo CAR-T therapy (STAT)
  • How ARPA-H is developing FDA-authorized AI agents, tested in clinical trials (STAT)
  • A Huntington’s researcher on the UniQure-FDA fray (STAT)
  • Pfizer seeks earlier use of Talzenna in prostate cancer with Phase 3 win (Endpoints)
  • Collegium is acquiring Corium's approved ADHD drug for $650M (Endpoints)
  • Washington’s Medicaid program will pay for ElliQ, an AI robot for loneliness (Endpoints)
  • Updated: Lilly’s triple-G comparable with Mounjaro, first Phase 3 diabetes data suggest (Endpoints)
  • Exclusive: Congruence raises $40M, enters clinic with lead obesity drug (Endpoints)
  • Exclusive: Specialty care network company Lantern raises $30M (Endpoints)
  • US FDA approves J&J's oral psoriasis pill (Reuters)
  • After Alfasigma's GSK licensing deal, Lynavoy picks up FDA nod in rare liver disease (Fierce Pharma)
Medtech
  • Intuitive Surgical recalls stapler reloads over issue linked to patient death (MedTech Dive)
  • MiniMed gets FDA nod for smaller insulin pump (MedTech Dive)
  • JenaValve snags FDA approval in aortic regurgitation (MedTech Dive)
  • Cognito Shows Off More Positive Data For Device-Based Alzheimer’s Treatment (MedTech Insight)
  • JenaValve’s Trilogy Becomes First FDA-Approved TAVR Treatment For Aortic Regurgitation (MedTech Insight)
Food & Nutrition Government, Regulatory & Legal
  • HHS watchdog slams nursing homes’ antipsychotic drug use and schizophrenia diagnoses (STAT)
  • A Maryland legislator wants pharma and patient groups to disclose ties to disease awareness campaigns (STAT)
  • How a Texas couple is getting rich off out-of-network medical bills (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.
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