Eton Pharmaceuticals (ETON) announced that it has acquired the U.S. rights to Amglidia for the treatment of neonatal diabetes mellitus from AMMTeK. AMMTeK has conducted a post-approval study tracking five years of real-world safety and efficacy in European patients, which will be used to support Eton’s NDA submission. Eton plans to hold a meeting with the FDA in the first quarter of 2025 and anticipates submitting an NDA for the product in 2026.
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