Pfizer Inc.(NYSE:PFE) and Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX) announced today that the FDA has approved ELELYSO (taliglucerase alfa) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease. The label is available HERE.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today gave an update on its Complete Response Letter (CRL) received in March 2012 for Northera (droxidopa). A meeting with the FDA is scheduled to take place in May with formal meeting minutes likely by the end of May. At this time the company will host a conference call to discuss the path ahead for Northera.