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FDA Approves Tregzi (Orca-T) for GvHD Prophylaxis
The US Food and Drug Administration (FDA) approved Tregzi (Orca-T) on 30 June 2026, making it the first regulatory T cell-based immunotherapy authorised to improve chronic graft-versus-host disease (cGvHD)-free survival in adults undergoing matched donor allogeneic haematopoietic stem cell transplantation (allo-HSCT) for haematological malignancies. Developed by Orca Biosystems, Inc. (Orca Bio), Tregzi combines purified haematopoietic stem and progenitor cells (HSPCs), regula
Jul 2812 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
Guiding Principles of Good AI Practice in Drug Development: What Every Regulatory Professional Needs to Know
In January 2026, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) jointly published one of the most significant regulatory science documents in recent memory: Guiding Principles of Good AI Practice in Drug Development. For the first time, the world's two most influential regulatory authorities have aligned on a shared framework governing how artificial intelligence must be developed, validated, documented, and managed across the entire pharm
Jul 912 min read
How to Move from Pharmaceutical Scientist to Regulatory Affairs
If you’re a scientist working in the pharmaceutical industry and feeling stagnant, a move into regulatory affairs could be the most strategic career decision you ever make. Here’s everything you need to know about how to make it happen. The Problem With Being “Experienced but Stuck” There’s a specific kind of career frustration that comes from doing everything right and still feeling like you’re going nowhere. You have a science degree — maybe a Master’s, maybe a PhD. You’v
Jul 96 min read
Revising EU GMP Annex 15: What the Concept Paper Means for the Industry
In January 2026, the EMA GMP/GDP Inspectors Working Group and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) jointly published a concept paper proposing the most significant revision to EU GMP Annex 15 in over a decade. The public consultation that followed — open from 9 February to 9 April 2026 — has generated substantial industry debate, and for good reason. What is being proposed is not a cosmetic update to existing guidance. It is a structural overhaul that w
Jul 912 min read
Joint Scientific Consultations (JSCs): What They Are and Who They Can Help
If you have spent any time navigating the EU Health Technology Assessment (HTA) landscape in 2025 or 2026, you will have encountered a question that stops many development teams in their tracks: how do we design a clinical trial that satisfies both the EMA for marketing authorisation and EU HTA bodies for the Joint Clinical Assessment — when their evidence requirements do not always align? The answer, in regulatory terms, is the Joint Scientific Consultation (JSC) — one of
Jul 816 min read