FDA

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The US FDA has approved a fourth product via its new National Priority Voucher Programme - a 7.2 mg dose of Novo Nordisk's weight loss drug Wegovy.

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New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.

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The FDA stops short of approving leucovorin for autism, but will its clearance for ultra-rare condition CFD-FOLR1 lead to more off-label prescribing?

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The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.

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For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.

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Shares in PepGen fell sharply after the FDA placed a partial clinical hold on its lead drug for rare neuromuscular disease DM1.