regulatory approval

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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.

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Rocket Pharma has won FDA approval for the first gene therapy for LAD-I, a devastating genetic disorder causing severe vulnerability to infections.

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Corcept shares surge on FDA approval of Lifyorli, a first-in-class selective glucocorticoid receptor antagonist for ovarian cancer.