regulatory approval

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

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AstraZeneca and Daiichi Sankyo's Datroway enters the first-line triple-negative breast cancer market in the EU, taking on Gilead's Trodelvy.

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Pfizer's JAK inhibitor Litfulo hits the mark in vitiligo, setting up filings, as Incyte claims EU approval for Opzelura in atopic dermatitis.