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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
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
10 Clinical Trials to Watch in H2 2026: From Lung Cancer Immunotherapy to Personalised Cancer Vaccines — A Regulatory Affairs Briefing
The most closely watched clinical trials to watch in H2 2026 span lung cancer immunotherapy, personalised mRNA cancer vaccines, obesity drugs, rare neuromuscular disease and novel anticoagulants, according to industry tracking from BioPharma Dive. These trials affect oncologists, biotech investors, sponsors and regulatory affairs teams preparing dossiers across the FDA, EMA and MHRA. Readouts expected between July and December 2026 will shape marketing authorisation strategy,
Jul 1012 min read