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Novo Nordisk A/S

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Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the label cite eligibility criteria used in clinical trials, responding to a citizen petition on the day the agency approves the therapy.

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Demand-related shortages are a relatively new problem, but FDA maintains its tools can prevent or end them.

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The drug is dosed once every four weeks – compared with Mounjaro and Wegovy’s weekly dosing – but the company also signaled it is considering extended dosing intervals.

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To Prevent Shortages, US FDA Wants Sponsor To Provide Notifications Of Demand Spike

Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.

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