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In September 2023, FDA placed "Thymosin Beta-4, Fragment (LKKTETQ)," the substance sold as TB-500, on Category 2 of its interim 503A bulk drug substances list, meaning FDA identified significant safety concerns and would not permit licensed compounding pharmacies to use it

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The tablets used in the single-dose trial contained synthetic semaglutide and the manufacturing included a wet granulation step, while those in subsequent trials contained recombinant semaglutide and the manufacturing included a dry granulation step