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In its announcement of the Complete Response Letter, Citius said the FDA will require it to incorporate enhanced product testing and additional controls into the BLA

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This combination synergistically increases disease progression and HCC risk significantly compared to obesity or alcohol alone (Gratacos-Gines et al., 2025

Foods and Habits That Make Side Effects Worse While there is no official dietary restriction list for semaglutide, clinical experience consistently identifies these as common triggers for worsened GI symptoms: High-fat foods: fried foods, fast food, heavy creamy sauces Very sugary foods and drinks Carbonated beverages (increase bloating and gas) Alcohol (worsens nausea and GI irritation