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The latest drug approval announced by the FDA is a reminder that...

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    The latest drug approval announced by the FDA is a reminder that it's possible that the decision on trofinetide could come any day now.

    The FDA has approved Chiesi Global Rare Diseases’ velmanase alfa (Lamzede), an enzyme replacement therapy for the treatment of alpha-mannosidosis.

    Chiesi received notice of acceptance of its BLA and granting of priority review on 12 September, 2022, the same day on which Acadia received acceptance of its NDA and granting of priority review.

    https://www.fda.gov/drugs/new-drugs...biological-products/novel-drug-approvals-2023

    https://chiesirarediseases.com/media/pr-on-lamzede-9_12_22
 
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