text: Pomalidomide was submitted for FDA approval on April 26, 2012 and on 21 June it was announced that the drug would get standard FDA review. A marketing authorization application was filed to EMA 21 June 2012, where a decision could come as soon as early 2013. EMA has already granted pomalidomide an orphan designation for primary myelofibrosis, MM, systemic sclerosis, post-polycythaemia and post-essential thrombocythaemia myelofibrosis.