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
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
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