Market Access News | pharmaphorum

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MSD and Daiichi Sankyo's regulatory efforts for their ADCs for cancer have stuttered again, with a withdrawn filing for lung cancer candidate I-DXd.

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Mirum's new oral therapy for rare bone disease fibrodysplasia ossificans progressiva (FOP) looks set to challenge Regeneron's intravenous Pasatru.

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Neuraxpharm and Minoryx' Nezglyal has become the first approved drug therapy in the EU for rare neurodegenerative disease cALD.

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AstraZeneca is closing on FDA approval of a new bladder cancer indication for Imfinzi that could help to fend off encroachment from MSD's Keytruda.

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Trump's FDA nominee Heidi Overton was quizzed on a range of issues at her Senate hearing, including vaccines, the abortion pill, and agency reforms.

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The FDA has approved Eli Lilly's once-weekly basal insulin product Onswik, setting up a market tussle with Novo's recently launched Awiqli.