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FDA Approves Drug Elosulfase Alfa (Vimizim™) for Muco...
May 1, 2014 - Featured , In the News / Politics By: Erica Dimitropoulos Co-Copy Editor [Content- Focused] – On February 14, 2014, elosulfase alfa (Vimizim™) became an FDA-approved enzyme replacement therapy for Morquio A Syndrome, a type of mucopolysaccharidosis (MPS IVA).1 Elosulfase alfa was granted priority review and was also the first drug to receive the Rare Pediatric Disease Priority Review Voucher that motivates the development… |
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After 15 Years, First New Recombinant Coagulation Facto...
October 1, 2013 - Clinical By: Tamara Yunusova, Senior Staff Editor – After a lengthy fifteen-year hiatus in recombinant drug approvals, FDA-approved Recombinant Coagulation Factor IX (Rixubis) has mounted to the forefront of Hemophilia B drug therapy. The recombinant coagulation factor gained orphan drug approval on June 26, 2013 for routine prophylaxis, control of bleeding episodes, and perioperative management in… |
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Varizig® for Chickenpox Symptoms...
January 1, 2013 - In the News / Politics By: Steve Soman, Co-Editor-in-Chief – Varicella Zoster Immune Globulin (Varizig®) was approved by the FDA on December 21st of 2012. The Canadian pharmaceutical company Cangene Corporation, which is owned in-part by Apotex Inc., markets the new product. The drug was approved by the Food and Drug Administration (FDA) to reduce “the severity of chicken pox… |