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The Denmark-based company announced Wednesday it had received a Complete Response Letter for dasiglucagon, which it was proposing for the ultra-rare genetic disease congenital hyperinsulinism, “due to the timing of a third-party manufacturing facility reinspection.” In an initial visit, the FDA had flagged “deficiencies” in a third-party contract manufacturer, which the company claims had been resolved by the time of a reinspection in August/September 2024
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