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Hemophilia A News
FDA Approves Alhemo as Once-Daily Prophylactic Treatment to Prevent or Reduce the Frequency of Bleeding Episodes for Adults and Children 12 Years of Age and Older with Hemophilia A or B (HA/HB) Without Inhibitors
PLAINSBORO, N.J., July 31, 2025 /PRNewswire/ – Novo Nordisk announced today that the US Food and Drug Administration (FDA) approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to p...
Efanesoctocog Alfa Not Cost-Effective for Prophylaxis in Hemophilia A
MONDAY, April 28, 2025 – For U.S. patients with severe hemophilia A, prophylaxis with efanesoctocog alfa is neither conventionally nor distributionally cost-effective, according to a study published...
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...
FDA Approves Roctavian (valoctocogene roxaparvovec-rvox) Gene Therapy for Adults with Severe Hemophilia A
SAN RAFAEL, Calif., June 29, 2023 /PRNewswire/ – BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today...
FDA Approves Altuviiio ([Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl]) Once-Weekly VIII Therapy for Hemophilia A
Paris and Stockholm – February 23, 2023 – The U.S. Food and Drug Administration (FDA) has approved Altuviiio™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl], previously refer...
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 Medwatch Alert: Bayer Statement on Voluntary Recall of Two Lots of Kogenate FS Antihemophilic Factor (Recombinant) in the United States
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled...
FDA Approves Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A
Bagsværd, Denmark, 19 February 2019 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for Esperoct for the treatment of ...
FDA Approves Genentech’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
South San Francisco, CA – October 4, 2018 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved...
Bayer Receives FDA Approval for Jivi (antihemophilic factor (recombinant), PEGylated-aucl) for Prophylactic Treatment of Hemophilia A
WHIPPANY, N.J., Aug. 30, 2018 /PRNewswire/ – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] ...
FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors
November 16, 2017 – The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with...
Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical Settings
Lexington, Mass. – December 27, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Adynovate [Antihemophilic Factor (Recombinant), ...