regulatory approval

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PTC Therapeutics' chief executive Matthew Klein.

Germany will be first launch for PTC's phenylketonuria drug

PTC Therapeutics' treatment for the rare disease PKU, Sephience, will launch in its first market next month after getting EU approval.

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AZ, Daiichi get Datroway nod in lung cancer on second try

AZ and Daiichi Sankyo have claimed FDA approval for Datroway in lung cancer after switching indications for the TROP2-directed drug.

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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?

Germany will be first launch for PTC's phenylketonuria drug

AZ, Daiichi get Datroway nod in lung cancer on second try

Dupixent is first FDA-approved drug for rare skin disease

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

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

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

Lilly's 'triple G' retatrutide aces crucial obesity trial

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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