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In October 2021, the drug manufacturer submitted a marketing authorisation application to the EMA and a priority review voucher to the US FDA for the regulatory approval of tirzepatide in type 2 diabetes, leading to an expected review time of 8 months from the date of submission [12]
16 The emerging evidence strongly suggests that GLP-1 RAs hold significant promise not only in addressing diabetes and obesity but also in the realm of treating psychiatric disorders
In 2023 BPC-157 and a group of related research peptides were placed by the FDA into the interim category 2 list of bulk drug substances that may present significant safety risks a status reflecting immunogenicity, impurity, and human-safety concerns rather than a clean bill of health
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