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FDA Approves Lumvoa (Veligrotug-vvze) for Thyroid Eye Disease — What Regulatory Affairs Professionals Need to Know
The US Food and Drug Administration (FDA) approved Lumvoa (veligrotug-vvze) on 26 June 2026, making it the first therapy indicated for both active and chronic thyroid eye disease (TED). Developed by Viridian Therapeutics, Lumvoa is a full antagonist of the insulin-like growth factor-1 receptor (IGF-1R), delivered as five intravenous infusions over 12 weeks — a shorter course than the existing standard of care. Approval was supported by the pivotal Phase 3 THRIVE and THRIVE-2
Jul 812 min read
How to Get Into Regulatory Affairs With Pharmaceutical Industry Experience (But No RA Background)
You work in pharma. You want to move into regulatory affairs. You’re applying and not getting through. Here’s exactly why — and exactly what to do about it. You Already Work in the Industry. Why Is RA Still Out of Reach? It seems like it should be straightforward. You work in the pharmaceutical industry — in quality, in manufacturing, in analytical development, in clinical operations, in biomedical science or hospital pharmacy. You understand how the industry works. You kno
Jul 85 min read
Career Options for PhD Scientists Beyond Academia: Why Regulatory Affairs Stands Out
If you’re a PhD scientist or postdoctoral researcher looking to move beyond academia or bench science, this guide covers everything you need to know about regulatory affairs as a career — including how to make the transition quickly and effectively. There’s a moment that most PhD scientists and postdoctoral researchers recognise. It usually comes somewhere in the second or third year of a postdoc, or after a few years in an industry research role. You’ve invested more than
Jul 75 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
New PRIME Tools to Accelerate Development of Medicines in the EU: What It Means for Industry and Regulatory Careers
In March 2026, the European Medicines Agency (EMA) made a landmark announcement. After completing a two-year pilot programme, the agency formally launched three major new features under its PRIME (PRIority MEdicines) scheme — powerful tools designed to improve how innovative medicines reach patients across the European Union. For pharmaceutical developers, biotech companies, and the regulatory professionals who support them, this is not a routine administrative update. It rep
Jul 213 min read
How to Advance Your Regulatory Affairs Career to Manager and Director Level
Already working in regulatory affairs but feeling stuck? Here’s a comprehensive guide to what separates those who plateau from those who progress — and what you can do to accelerate your career. The Mid-Level RA Career Problem Regulatory affairs is widely regarded as one of the most rewarding and well-compensated careers in the pharmaceutical industry. And yet, a significant proportion of RA professionals at Associate and Officer level find themselves in a frustrating posit
Jun 255 min read