--- title: 'Regulatory Daily Summary: What Happened on November 2, 2026' headline: Ultragenyx wins first European approval for Dojolvi description: The FDA approved Ilumya for adults with active psoriatic arthritis, while Pretzel secured UK trial authorization for PX578. url: https://thebench.bio/news/regulatory/2026-11-02 topic: regulatory date: '2026-11-02' covers: - '2026-11-02' date_published: '2026-11-02T12:01:51Z' date_modified: '2026-11-02T12:01:51Z' tags: - Regulatory - Industry sources: 5 publisher: TheBench.Bio --- # Regulatory Daily Summary: What Happened on November 2, 2026 **Ultragenyx wins first European approval for Dojolvi** The FDA approved Ilumya for adults with active psoriatic arthritis, while Pretzel secured UK trial authorization for PX578. ## Today in brief Dojolvi has received its first European approval, giving Ultragenyx its first European nod for the rare-disease drug. [1] Ilumya is now approved in the US for adults with active psoriatic arthritis. [2] ## Also worth knowing - Pretzel Therapeutics received UK authorization for a Phase II trial of PX578 in people with POLG-mediated mitochondrial disorders. The company expects to start the study before the end of 2026. [3] - Hutchmed and AstraZeneca filed Orpathys for lung cancer based on data presented at ESMO. [4] - Walmart is expanding its clinical trial centers into three additional states. [2] - Inovio shares rose 2.5-fold after a plasmid DNA drug was approved. [5] - Ultragenyx received the first European approval for Dojolvi, a drug for a rare disease. [1] - The FDA approved Ilumya for adults with active psoriatic arthritis. [2] ## The day in numbers - **3 states**: Additional states where Walmart plans to expand its clinical trial centers. [2] ## Also published - [MHRA launches patient safety essay competition for MedSafetyWeek](), MHRA ## Sources 1. [Ultragenyx gets first Euro nod for rare disease drug Dojolvi](), pharmaphorum, 2026-11-02 2. [ACT Brief: Community Research Policy Needs, Walmart Trial Centers, and Psoriatic Arthritis Approval](), Applied Clinical Trials, 2026-11-02 3. [Pretzel gains UK approval for PX578 trial to treat mitochondrial disorder](), Clinical Trials Arena, 2026-11-02 4. [Hutchmed, AZ file Orpathys for lung cancer on ESMO data](), pharmaphorum, 2026-11-02 5. [Inovio stock rises 2.5-fold on plasmid DNA drug approval](), pharmaphorum, 2026-11-02 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: