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Gastrointestinal side effects including loose stools commonly occur when starting semaglutide therapy, particularly during dose escalation phases

Unlike the chaotic rollout of injectable Wegovy, which was plagued by shortages, the company has already boosted production to prepare for demand

Medical supervision with baseline biomarkers and regular monitoring is essential for safe combined use

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