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FDA Approves Needle-Free Transfer Device for Hemophilia A Product

March 31, 2016

Note: The following in an edited press release from Kedrion Biopharma. The original release can be read in its entirety here. Kedrion Biopharma has gained approval from the U.S. Food and Drug Administration to package Koāte® Double Viral Inactivation (DVI) Antihemophilic Factor (human) with Mix2Vial™, a needle-free transfer device. The new packaging is designed to offer hemophilia […]

FDA Approves New Recombinant Factor Following LEOPOLD Trials

March 17, 2016

Note: The following is an edited version of a press release from Bayer. The original press release can be found here.  The U.S. Food and Drug Administration (FDA) has approved Bayer’s KOVALTRY® Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based […]

Community Voices: An Inhibitor On The High Seas

February 16, 2016

Justin Levesque (pictured in the orange hat), poses with the crew aboard a ship bound for Iceland.  __________________________________________ Justin Levesque has severe hemophilia with an inhibitor. Justin recently had an opportunity of a lifetime when he spent nine days aboard a ship to Iceland as part of an art project that he developed. In this […]

Octapharma Announces US Availability of NUWIQ

January 4, 2016

 Note: The following is an edited press release from Octapharma USA. The original release can be read in its entirety here. Octapharma USA announced on Monday, January 4, 2016 that NUWIQ®, Antihemophilic Factor (Recombinant), is now commercially available. NUWIQ® is indicated for the treatment and control of bleeding, perioperative (surgical) management, and routine prophylaxis to reduce […]

Update #2: SIPPET Study

December 10, 2015

This past weekend, the American Society of Hematology (ASH), a worldwide organization of 15,000+ medical and scientific experts on blood diseases, held their 57th Annual Meeting to discuss new treatments and research methods. During this meeting, a group of doctors from around the globe presented the findings of the Survey of Inhibitors in Plasma-Product Exposed Toddlers (SIPPET). […]

FDA Approves Twice-Weekly Hemophilia A Treatment

November 16, 2015

Note: The following is an edited version of a press release originally published by Baxalta. The original release can be read here. Baxalta Incorporated announced on Monday, November 16, 2015, that the U.S. Food and Drug Administration (FDA) has approved ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia […]

FDA Approves New Octapharma Treatment For Patients With Hemophilia A

September 15, 2015

Note: This is an edited form of a press release from Octapharma. To read the original release in its entirety, click here. Octapharma USA announced on September 15, 2015, that the U.S. Food and Drug Administration (FDA) has approved NUWIQ®, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children living with Hemophilia A. The NUWIQ® […]


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