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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
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
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