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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
10.1016/s0969-9961(03)00087-1 153 HetzC.SaxenaS
Molecules 28(2):887
Happy days at last
J Plant Physiol 164(5):601610
BSO (buthioninesulfoximine) decreases intracellular levels of glutathione and thereby overcomes resistance to alkylating agents [47]
