FDA

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FDA has started its review of an autoinjector version of Eisai and Biogen's Alzheimer's drug Leqembi that could allow patients to be dosed at home.

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The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area.

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Novo Nordisk has asked the FDA to block compounders from making versions of its older, once-daily GLP-1 agonist liraglutide.

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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.