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TransThera's Yochanra has been cleared in China as the world's first drug that can overcome resistance to FGFR inhibitors in cholangiocarcinoma.

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At its third attempt, Replimune has finally won FDA approval for its advanced melanoma treatment RP1, now named Tudriqev and its first product.

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A Dutch compounding pharmacy has been ordered to stop distributing a compounded nasal spray version of Novo Nordisk's GLP-1 agonist semaglutide.

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Takeda's orexin agonist Orzeyful is the first drug approved in the US that can treat the "full range" of narcolepsy type 1 symptoms, says the FDA.

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CDC has a permanent director in place at last, after the Senate confirmed Erica Schwartz's nomination to what has become a politically charged role.

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After a series of regulatory twists and turns, the FDA has approved Moderna's mRNA-based influenza vaccine mFlusiva.