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fda bpc-157 warning letter unapproved new drug On August 15 2025, the U.S. Food & Administration (FDA) issued a to Platinum Biologics LLC for marketing umbilical‑cord‑derived products including exosome products (“NanoEx” & “Nano Xsomes”) without approval Choose Your Bundle:1 Pack niacin injection BAC Water vs Sterile

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Two randomized, placebo-controlled clinical trials were conducted at separate clinical centers using consistent protocols for medication, injection method (periodontal tissue injection), inclusion and exclusion criteria, and outcome assessments

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