regulatory

News

FDA advisors have voted that the benefit/risk profile of GSK's multiple myeloma therapy, Blenrep, does not support its approval in the US.

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Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy, a major cause of blindness.

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The WHO has recommended Gilead's twice-yearly HIV PrEP drug lenacapavir, calling it 'transformational', but there are concerns about patient access.

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The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.

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Nine adverts for weight-loss services have been banned by the Advertising Standards Authority in the UK for promoting prescription-only drugs.

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Novo Nordisk has moved quickly to file for approval of a higher-dose version of obesity drug Wegovy as it fends off stiff competition from Eli Lilly.