Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholang
After two FDA rejections for non-alcoholic steatohepatitis (NASH) therapy obeticholic acid (OCA), Intercept Pharma has agreed to be taken over by Italian drugmaker Alfasig
Intercept Pharma has conceded defeat in its battle to get obeticholic acid (OCA) approved as a treatment for non-alcoholic steatohepatitis (NASH) after the FDA rejected it
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.
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China and Japan gave a green ligh