Recon: FDA rejects AstraZeneca’s lupus therapy Saphnelo; MAHA movement turns to dismantle state vaccine laws
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- New data shows how HHS is implementing Trump AI mandates (STAT)
- FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy (STAT)
- AstraZeneca gets CRL for self-injectable pen version of lupus drug Saphnelo (Endpoints)
- Buoyed by Kennedy's success, MAHA groups take aim at state vaccine laws (Reuters)
- Senior FDA Official Under OIG Investigation Over Divorce, Assets (Bloomberg)
- Wegovy maker Novo Nordisk appoints Jamey Millar head of its US business (Reuters)
- From Croatia to MAHA: How an unapproved drug became the next hot peptide (STAT)
- WHO says first five patients evacuated via Gaza's Rafah crossing (Reuters)
- Acceptance Of Foreign Clinical Data Enshrined In China’s Revised Drug Law (Pink Sheet)
- Regulatory tracker: Acadia expects EU snub in Rett syndrome (Fierce Pharma)
- Novo Nordisk's next-gen obesity drug outperforms Wegovy in late-stage diabetes trial (Reuters)
- Pfizer moves forward with its hopes for a monthly obesity drug (STAT)
- Pfizer’s Metsera-originated monthly GLP-1 cuts weight by 10.5% at six months (Endpoints)
- Ultragenyx unwraps data that may be central to its gene therapy resubmission (Endpoints)
- Exclusive: Stanford duo joins AI scientist race with startup backed by a16z and Menlo (Endpoints)
- Carbon Health files for bankruptcy, seeking to sell or restructure (Endpoints)
- Novo Nordisk’s CagriSema bests semaglutide in type 2 diabetes study (Endpoints)
- GSK gives back rights to Wave Life Sciences' lead RNA editing program (Endpoints)
- Merck's 2026 outlook clouds upbeat fourth-quarter results (Reuters)
- AbbVie has ‘Love in Mind’ with new migraine educational campaign (Fierce Pharma)
- Boosting Your Brain With a Chip Carries a Price (Bloomberg)
- Medical device maker Medtronic to buy CathWorks in up to $585 million deal (Reuters)
- Beta Bionics receives FDA warning letter (MedTech Dive)
- STAAR names interim co-CEOs amid search for permanent leader (MedTech Dive)
- Time’s Up! QMSR Is Here. Device Makers Must Comply With New Regulatory Scheme (MedTech Insight)
- France Lowers Limit for Toxin in Baby Formula, May Spark Recalls (Bloomberg)
- McCormick tackles $50M tariff hit through pricing, other measures (Food Dive)
- First 10 Medicare-negotiated drug prices have taken effect: Are seniors really saving money? (Endpoints)
- We asked whether principal investigators have plans in place for how research can continue without them (STAT)
- AI could soon renew prescriptions without clinician help. Should the FDA make sure it’s safe? (STAT)
- STAT Plus:As U.S. officials move to reduce animal testing in research, focus may shift to restrictions on imports (STAT)
- Fearing ICE crackdown, immigrants nationally are avoiding treatment, sometimes with dire consequences (STAT)
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