This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

When the US FDA approved Olumiant (baricitinib) for RA, it insisted on a lower dose because of fears of blood clots. Now that an NIH trial has shown that the product plus Gilead’s Veklury (remdesivir) provided a statistically significant reduction in time to recovery versus remdesivir alone for hospitalized COVID patients, Olumaint may get an emergency use authorization from FDA to treat a condition that itself causes blood clots. That doesn't mean the black box is going away; it's just a reminder that there is as much magic and mystery to medicine sometimes as there is science. 

Givinostat, Italfarmaco’s investigational treatment for Duchenne muscular dystrophy, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.