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uniQure set for May FDA verdict on Huntington's gene therapy
The FDA has started its review of uniQure's gene therapy for neurodegenerative disorder Huntington's, but will require an advisory committee meeting.
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Ultragenyx gets first Euro nod for rare disease drug Dojolvi
Several years after its US approval, Ultragenyx's therapy for long-chain fatty acid oxidation disorders, Dojolvi, has been greenlit in the UK.
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Fresenius doubles down on biosimilars with big WuXi alliance
Fresenius is already a player in the biosimilars market, and has ramped up its position via a deal with WuXi Bio that spans up to 37 candidates.
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Hutchmed, AZ file Orpathys for lung cancer on ESMO data
Hutchmed/AstraZeneca's Orpathys is now under review in Europe and Japan for MET-driven/EGFR-mutated lung cancer, shortly after it was filed in the US.
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