Intercept Pharma is facing an uphill battle to get FDA approval of its OCA therapy for non-alcoholic steatohepatitis (NASH) once again, after FDA advisors comprehensively
Intercept Pharma’s hope that its OCA candidate could become the first FDA-approved drug to treat non-alcoholic steatohepatitis (NASH) is starting to look decidedly faint.
Intercept Pharma's hopes of getting its non-alcoholic steatohepatitis (NASH) therapy obeticholic acid (OCA) in the US may have taken another dive, after it flunked a phase 3 trial.
Intercept Pharmaceuticals has accused the FDA of moving the goalposts during its review of a potential blockbuster drug for the fatty liver disease known as NASH following a rejection.