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Regulatory Affairs News
Get the latest regulatory affairs news and insights on how your regulatory submission will be affected and how to make the updates.
Scientists Found a Hidden Immune Organ Inside the Human Skull — What It Means for Brain Cancer Treatment and Regulatory Affairs
Scientists at Washington University School of Medicine in St. Louis have identified a **skull immune organ** — lymphoid structures inside the skull's bone marrow that act as first responders to brain disease. Published in *Nature* on 19 August 2026, the study shows microscopic channels carry antigens from the brain into skull marrow, where **T follicular helper cells** train **B cells** to fight threats, including glioblastoma, before distant lymph nodes react. Similar cells
Aug 2812 min read
Big Pharma's Q2 2026 Profits Are In — But Are Patients Still Losing Out on Affordable Medicines?
Big Pharma's Q2 2026 earnings** season, which concluded in early August, showed record profits and raised full-year guidance across most major manufacturers, even as US patient affordability data worsened. This affects patients paying out of pocket in the United States, pharmaceutical companies navigating new pricing regulation, and regulatory affairs professionals working across market access and lifecycle management. It matters now because the Medicare Drug Price Negotiatio
Aug 1413 min read
UK Launches New MHRA Regulatory Sandbox for AI-Enabled Medical Devices: What London Region I Means for Regulatory Affairs
The MHRA AI regulatory sandbox for medical devices, known as London Region I, allows up to 10 AI-enabled medical device manufacturers to deploy their technologies in real NHS clinical settings under regulatory oversight while generating real-world safety and effectiveness evidence. This affects AI medical device manufacturers, NHS providers across London, and UK regulatory affairs professionals working in medical devices. It applies from the Expression of Interest stage opene
Aug 1413 min read
GSK's £400m Cambridge Global Centre of Excellence: What the Investment Means for UK Life Sciences and Regulatory Affairs Careers
GSK's £400 million Cambridge investment will fund a new flagship research and development centre on the Cambridge Biomedical Campus, housing more than 1,000 scientists and replacing GSK's long-standing Stevenage site by 2029. Announced on 28 July 2026, the move forms part of a wider £1.9 billion cost-savings programme and is framed by the UK government as evidence that its Modern Industrial Strategy is attracting investment into life sciences. For regulatory affairs professio
Jul 3112 min read
MHRA and UK Space Agency Establish the World's First Regulatory Pathway for In-Orbit Pharmaceutical Manufacturing — Roadmap Due Autumn 2026
The UK has published the world's first regulatory pathway for space-manufactured medicines. Learn what the MHRA and UK Space Agency announced and what it means for regulatory professionals. The meeting point between the global space economy and the pharmaceutical industry has been building for decades. Since the first protein crystallisation experiments aboard the International Space Station (ISS) in the early 2000s, researchers have understood that microgravity — the near-we
Jul 218 min read