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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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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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Inovio stock rises 2.5-fold on plasmid DNA drug approval
Inovio Pharma's plasmid DNA-based Voceryq has become the second drug approved in the US for adults with recurrent respiratory papillomatosis.
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HHS doubles down on controversial peptides plan
HHS unveils an enforcement holiday to manufacture of unapproved peptides - before the FDA decides if they should be allowed in compounded medicines.
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