Regulatory Daily Summary
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.
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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
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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
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Hutchmed and AstraZeneca filed Orpathys for lung cancer based on data presented at ESMO.4
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Walmart is expanding its clinical trial centers into three additional states.2
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Inovio shares rose 2.5-fold after a plasmid DNA drug was approved.5
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Ultragenyx received the first European approval for Dojolvi, a drug for a rare disease.1
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The FDA approved Ilumya for adults with active psoriatic arthritis.2