It’s not unusual for drug regulators from different countries to take quite different stances on whether a new medicine should be approved for marketing. Stemline Therapeutics, Inc.’s orphan medicine Elzonris (tagraxofusp), whose EU authorization in January came two years after its approval in the US, is a striking example of just how far agencies’ views can diverge.
Elzonris was initially granted accelerated assessment (AA) by the European Medicines Agency, but later lost this status because the number...
