regulatory approval

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Dupixent is first FDA-approved drug for rare skin disease

The long list of therapeutic uses for Sanofi and Regeneron's Dupixent has been lengthened by an FDA approval for rare skin disease bullous pemphigoid.

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Gilead's twice-yearly PrEP drug is cleared by FDA

Gilead has FDA approval for a twice-yearly PrEP drug, but could proposed cuts to US funding for HIV prevention programmes hinder its take-up?

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FDA green lights CSL's once-monthly HAE drug Andembry

CSL has won FDA approval for Andembry, its once-monthly subcutaneous drug to prevent hereditary angioedema (HAE) attacks.

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Stéphane Bancel, Moderna's chief executive

Moderna's RSV shot gets US nod for use in younger adults

The label for Moderna's RSV vaccine mResvia has been expanded to include adults aged 18 and over in the US, but will that lead to an uptick in sales?

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FDA clears Nuvation's first product Ibtrozi, for lung cancer

Nuvation is set to launch its first commercial product after the FDA approved its ROS1 inhibitor Ibtrozi as a treatment for ROS1-positive lung cancer.

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