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Archives Internationales de Pharmacodynamie et de Thrapie

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Bruin, E

Gonadotropin-releasing hormone (GnRH) drives luteinizing hormone (LH) and follicle-stimulating hormone (FSH) release

And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question

In the TRIUMPH-1 Phase 3 trial, participants on the maximum dose of retatrutide (12 mg) lost an average of 28.3% of their body weight after 80 weeks, and up to 30.3% after 104 weeks in the study extension