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hepatotoxicity

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Navigating Drug-Induced Liver Injury in Clinical Trials: Insights and Updates from FDA Experts
Posted inGastroenterology Internal Medicine news

Navigating Drug-Induced Liver Injury in Clinical Trials: Insights and Updates from FDA Experts

Posted by By MedXY 09/07/2026
Drug-Induced Liver Injury (DILI) remains a pivotal challenge in drug development, with evolving drug modalities and clinical trial designs prompting updated regulatory perspectives from FDA specialists.
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Postmarketing Data Link Fezolinetant Primarily to Early Transaminase Elevations Rather Than Overt Liver Injury
Posted inGastroenterology news OB/GYN & Women’s Health

Postmarketing Data Link Fezolinetant Primarily to Early Transaminase Elevations Rather Than Overt Liver Injury

Posted by By MedXY 06/01/2026
FAERS postmarketing data suggest fezolinetant is associated with an early hepatic adverse event reporting signal, driven mainly by liver enzyme elevations rather than consistent severe clinical liver injury.
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