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Essential Extras: An additional violation noted in the Form 483 FDA inspection report but corrected before the warning letter was issued was for vermin infestation due to the observation of a live spider in the production area and a dead cricket in the middle of the incubator room. Telehealth company Hims & Hers acquired MedisourceRx in September 2024, allowing it to bring much of its drug compounding operations in-house

In participants without a prior history of heart failure, the drug did not significantly reduce heart failure events

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This may be due to preserved endogenous GLP-1 activity, lower baseline insulin resistance, or PD-related hypothalamic dysfunction affecting appetite signaling