The FDA's September 2025 and March 2026 enforcement actions establish that "research use only" labeling does not exempt a product from federal requirements when it is in fact marketed for human use
other lymphadenopathy persisting for 4-6 weeks Progressive growth : Nodes that continue to increase in size over time Hard, fixed, or irregular nodes : Lymph nodes that feel firm, immobile, or have an irregular texture may indicate serious pathology Generalised lymphadenopathy : Swelling in multiple lymph node regions (neck, armpits, groin) simultaneously Systemic symptoms : Unexplained fever, drenching night sweats, unintentional weight loss (beyond expected GLP-1-related weight reduction), or persistent fatigue Associated symptoms : Difficulty swallowing, breathing difficulties, or hoarseness accompanying neck lymphadenopathy According to NICE guideline NG12 , lymphadenopathy with concerning features should prompt consideration of a suspected cancer pathway referral (2-week wait)
[1] With once-weekly administration, a 10 mg vial generally serves as the baseline for a single high-dose treatment
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That does not mean every study will show the same pattern, but it does explain why dose escalation and tolerability are often discussed together