regulatory approval

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Axsome's Auvelity has become the first non-antipsychotic therapy for agitation in patients with Alzheimer's disease to be approved by the FDA.

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Patients in the EU with the ultra-rare disease WHIM syndrome now have their first approved treatment, Norgine's Xolremdi.

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Regeneron's Otarmeni is the first gene therapy for congenital hearing loss to be cleared by the FDA, and will be made available for free in the US.

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Shrugging off an earlier phase 3 disappointment, Travere’s Filspari has become the first FDA-approved treatment for rare kidney disease FSGS.

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Eli Lilly has claimed US approval for oral GLP-1 agonist orforglipron, setting up a market clash with Novo Nordisk's first-to-market Wegovy pill.

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The EU has approved UCB's Kygevvi for rare disease TK2d, and Sanofi's acute GvHD therapy Rezurock, in a pair of decisions announced this morning.