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(PubMed) Iyer R, Gupta A, Khan A, Hiremath S, Lokhandwala Y
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
GLP-1 receptor agonists, such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), have revolutionized weight loss and type 2 diabetes management
At room temperature up to 77 F, the unused pens can last up to 56 days
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