regulatory approval

News

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.

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Denali's Avlayah is the first drug for neurological complications associated Hunter syndrome to be approved in the US.

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Rhythm Pharma has secured the first approval in the US for a drug to treat hypothalamic obesity.

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Alfasigma has claimed the first approval, in the US, for linerixibat, a drug for liver disease PBC licensed from GSK for $690m a few days ago.

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Johnson & Johnson's much-anticipated oral IL-23 drug, icotrokinra, has claimed FDA approval as Icotyde for first-line treatment of plaque psoriasis.