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FDA's August 2026 PDUFA Wave: Five Landmark Decisions Regulatory Affairs Professionals Need to Know
The FDA PDUFA dates for August 2026 mark one of the busiest single-month regulatory windows of the year, with five separate Prescription Drug User Fee Act (PDUFA) decisions due between 5 and 28 August. The decisions affect a new mRNA influenza vaccine, an oral multiple myeloma therapy, a single-tablet HIV regimen, a radiopharmaceutical for neuroendocrine tumours, and a first-in-class treatment for an ultra-rare bone disorder. Sponsors include Moderna, Bristol Myers Squibb, Gi
Aug 712 min read
EMA OPEN Framework 2026 Update: What Pharma and Regulatory Affairs Teams Need to Know
The EMA OPEN framework (Opening Procedures at EMA to Non-EU Authorities) allows the European Medicines Agency (EMA) to run near-concurrent scientific assessments of certain medicines alongside seven non-EU regulatory partners, while each authority keeps full independence over its own decision. Originally piloted for COVID-19 medicines in December 2020, it was expanded to a wider range of therapeutic areas on 20 July 2023 and remains the operational basis for cross-border coll
Aug 511 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
Why 90% of Regulatory Affairs Applicants Get Zero Job Offers (And How to Be the 10%)
Most regulatory affairs applicants never get an interview. Learn why — and the specific CV, experience and training fixes that put you in the top 10%. The overwhelming majority of regulatory affairs job applications fail before a human ever reads the covering letter. This article explains what happens to those applications, who typically gets rejected, why relevant scientific and clinical experience is routinely overlooked, and what separates the small minority of candidates
Jul 3112 min read
How Pharmacists Can Move Into the Pharmaceutical Industry Through Regulatory Affairs
Community and hospital pharmacy is one of the most intellectually demanding qualifications in healthcare. Pharmacists spend four to five years studying pharmacokinetics, drug interactions, pharmaceutical sciences, clinical practice and patient counselling. They emerge with a depth of pharmaceutical knowledge that most people in the healthcare system simply don’t have. And then, for a significant proportion, they spend their careers in environments that use only a fraction of
Jul 284 min read
The EU HTA Regulation Is Reshaping How Clinical Evidence Supports Market Access Across Europe
On 30 April 2026, a milestone quietly passed that will redefine how innovative medicines reach patients across the European Union. The HTA Coordination Group (HTACG) approved the very first Joint Clinical Assessment (JCA) report in history — covering tovorafenib (Ojemda®), Ipsen's treatment for paediatric low-grade malignant glioma. Completed well within the 30-day timeline from marketing authorisation, it marked the first real-world product of a regulatory and market access
Jul 2814 min read