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Tentative Approval means the FDA confirmed the product meets all safety, efficacy, and manufacturing standards but it can't launch yet because existing patents or exclusivities still block the market

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Interim results from the ongoing Phase 2 COURAGE trial - investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity - demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass.The outcomes also demonstrated that combining semaglutide with trevogrumab with or without garetosmab helped preserve lean mass while increasing loss of