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Capricor files cell therapy for DMD cardiomyopathy with FDA

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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FDA approves flurry of drugs ahead of holiday season

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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Mesoblast finally pushes GvHD cell therapy over finish line

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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FDA clears Neurocrine drug for rare adrenal disorder

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 adds new indication for blockbuster hope Nemluvio

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

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Former congressman and doctor Dave Weldon has been nominated by Trump to lead the Centers for Disease Control and Prevention

Makary confirmed as Trump's FDA pick, with Weldon for CDC

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

Capricor files cell therapy for DMD cardiomyopathy with FDA

FDA approves flurry of drugs ahead of holiday season

Mesoblast finally pushes GvHD cell therapy over finish line

FDA clears Neurocrine drug for rare adrenal disorder

Galderma adds new indication for blockbuster hope Nemluvio

Makary confirmed as Trump's FDA pick, with Weldon for CDC

Patient organisations 'too influenced by corporate funders'

The AI effect in pharma commercial strategy: From data to re...

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