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Hemophilia B News
FDA Approves Qfitlia to Cut Bleeding Episodes in Patients With Hemophilia
WEDNESDAY, April 2, 2025 – The U.S. Food and Drug Administration has approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and...
FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without Inhibitors
Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the...
FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors
NEW YORK--(BUSINESS WIRE) October 11, 2024 – Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis...
FDA Approves Hympavzi for Hemophilia
TUESDAY, Oct. 15, 2024 – The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and...
Trial Confirms 'Life-Changing' Impact of Beqvez Gene Therapy for Hemophilia B
THURSDAY, Sept. 25, 2024 – A new gene therapy approved earlier this year can serve as a sustainable single-dose treatment for people with hemophilia B, newly published clinical trial data shows....
Fidanacogene Elaparvovec Superior to Prophylaxis for Hemophilia B
THURSDAY, Sept. 26, 2024 – For patients with hemophilia B, fidanacogene elaparvovec, an adeno-associated virus (AAV) gene-therapy vector for hemophilia B containing a high-activity human factor IX...
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...
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...