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Home » DILI pickle sours adcom vote on Intercept’s bid with OCA; ‘no read-across’ in NASH space?
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DILI pickle sours adcom vote on Intercept’s bid with OCA; ‘no read-across’ in NASH space?

May 19, 2023
By Randy Osborne
Trouble presaged by U.S. FDA concerns over potential drug-induced liver injury (DILI) caused by obeticholic acid (OCA) 25 mg came to pass during the Gastrointestinal Drugs Advisory Committee meeting May 19 on Intercept Pharmaceuticals Inc.’s accelerated approval effort with the compound.
BioWorld Regulatory Gastrointestinal FDA

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