The European Medicines Agency (EMA ... of the two drugs, but in the US the situation is a little different. Suicidal thinking and self-harm aren’t currently listed on the FDA-approved ...

For instance, "If using the criterion of drugs that were FDA approved in any indication and dose, the proportion of patient benefit in these trials rises to 38%, with a 51% benefit rate ...

The study, which has an FDA and EMA-approved protocol, will enroll patients in Europe, with the U.S. and Canada expected to follow. The randomized, double-blind, placebo-controlled study aims to ...