The European Medicines Agency (EMA) has begun a review of Ocaliva, a medicine used to treat primary biliary cholangitis (PBC), following the results of two studies. The studies failed to show that Ocaliva was more effective than a placebo, and side effects, including serious ones, occurred more frequently in patients treated with Ocaliva. The EMA will assess the impact of these findings on the overall benefit-risk balance of Ocaliva and make a recommendation on whether the medicine's marketing authorisation in the EU should be amended.