(Reuters) – The U.S. Food and Drug Administration said on Friday it approved Baxalta Inc's drug for use in patients with a type of rare bleeding disorder. The drug, Adynovate, was approved to control and reduce the frequency of bleeding episodes in patients with Hemophilia A, the agency said in a statement. Data from a late-stage study, which tested 137 patients, showed that Adynovate was effective in reducing and controlling bleeding episodes, compared with Advate.
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FDA approves Baxalta’s drug for rare bleeding disorder