FDA

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Capricor completes its US filing for deramiocel, vying to become the first FDA-approved therapy for cardiomyopathy in Duchenne muscular dystrophy.

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The FDA has wrapped up a series of new approvals as 2024 draws to a close, with Novo Nordisk, Pfizer, Vertex, and Hikma among the beneficiaries.

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At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

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Neurocrine Bioscience's Crenessity is the first new option for classic congenital adrenal hyperplasia (CAH) in more than 70 years.

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Galderma has claimed a second FDA approval for IL-31 inhibitor Nemluvio, adding atopic dermatitis to its label.

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Martin Makary has been confirmed as Donald Trump's pick for FDA Commissioner, while Dave Weldon has been selected as his pick for CDC Director