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Hemophilia B News
ISTH Issues Clinical Practice Guideline for the Treatment of Hemophilia
MONDAY, July 1, 2024 – In a clinical practice guideline issued by the International Society on Thrombosis and Haemostasis and published online June 13 in the Journal of Thrombosis and Haemostasis,...
FDA Approves Beqvez (fidanacogene elaparvovec-dzkt) One-Time Gene Therapy for Adults with Hemophilia B
NEW YORK--(BUSINESS WIRE) April 26, 2024 – Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved Beqvez™ (fidanacogene elaparvovec-dzkt) for the t...
FDA Approves Medexus's Supplemental Biologics License Application for Ixinity to Treat Hemophilia B in Pediatric Patients
Toronto, Ontario and Chicago, Illinois-- March 26, 2024 - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) today announced that the US Food and Drug Administration (FDA) recently approved Medexus's...
Concizumab May Be Effective Prophylaxis for Hemophilia A or B With Inhibitors
FRIDAY, Sept. 1, 2023 – Patients with hemophilia A or B with inhibitors have a lower annualized bleeding rate with concizumab than with no prophylaxis, according to a phase 3 study published online...
FDA Approves Hemgenix (etranacogene dezaparvovec-drlb) Gene Therapy for Hemophilia B
This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX...
Novo Nordisk Receives FDA Approval for Rebinyn (coagulation factor ix) for Routine Prophylaxis to Prevent Bleeding in Hemophilia B
PLAINSBORO, NJ, July 29, 2022 – Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Rebinyn®, Co...
FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors
LOUISVILLE, Ky., April 6, 2020 /PRNewswire/ – HEMA Biologics, LLC, ("HEMA Biologics") today announced that the U.S. Food and Drug Administration (FDA) approved Sevenfact® [coagulation factor VIIa ...
FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B
PLAINSBORO, N.J., May 31, 2017 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Rebinyn (Coagulation...
FDA Approves Idelvion (coagulation factor IX (recombinant), albumin fusion protein) to Treat Patients with Hemophilia B
March 4, 2016 – The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion...
Emergent BioSolutions Announces FDA Approval of Ixinity [coagulation factor IX (recombinant)] for Hemophilia B
GAITHERSBURG, Md., April 30, 2015 (GLOBE NEWSWIRE) – Emergent BioSolutions Inc. (NYSE:EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved Ixinity [coagulation factor...
FDA Approves Alprolix (recombinant coagulation factor IX) for patients with Hemophilia B
March 28, 2014 – The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix...
FDA Approves Rixubis - First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes
June 27, 2013 – The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis...