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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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Incyte claims EU approval for Zynyz as the first systemic therapy for anal cancer, as J&J gets the nod for wider use of Akeega in prostate cancer.

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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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Pfizer has claimed its first regulatory approval for a GLP-1 agonist in obesity, getting a green light in China for Sciwind-sourced ecnoglutide.

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J&J claims the FDA's third national priority voucher approval, advancing a Tecvayli-based regimen for multiple myeloma into the second-line setting.