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CytoDyn, Inc. was cited for promoting leronlimab, an investigational drug not yet approved by the FDA, as safe and effective for COVID-19 treatment through a video interview featuring the company's leadership that was posted on its corporate website. The promotional video violated the Federal Food, Drug, and Cosmetic Act by making conclusory claims about the drug's safety and efficacy in a promotional context before those claims had been established through FDA approval or authorization. The FDA emphasized the public health concern posed by promoting an unapproved investigational drug for a serious disease that can cause respiratory failure and death, particularly during the COVID-19 pandemic emergency declaration.