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Hemophilia A News
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 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 First Gene Therapy for Severe Hemophilia A, Roctavian
FRIDAY, June 30, 2023 – The U.S. Food and Drug Administration on Thursday approved a costly single-dose gene therapy for patients with severe hemophilia A. The treatment, Roctavian (valoctocogene...
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), ...
FDA Approves Afstyla (Antihemophilic Factor (Recombinant), Single Chain) for Hemophilia A
KING OF PRUSSIA, Pa. — 26 May 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved Afstyla [Antihemophilic Factor (Recombinant), Single Chain], its novel l...
FDA Approves Bayer's Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A
WHIPPANY, N.J., March 17, 2016 /PRNewswire/ – The U.S. Food and Drug Administration has approved Bayer's Kovaltry Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound...
FDA Approves Adynovate Modified Antihemophilic Factor for Hemophilia A
November 13, 2015 – The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who...
FDA Approves Nuwiq (Antihemophilic Factor [Recombinant]) for Hemophilia A
HOBOKEN, N.J. September 15th, 2015: Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Nuwiq, Antihemophilic Factor (Recombinant), an intravenous therapy for...
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