Fidanacogene Elaparvovec Gene Therapy Demonstrates Long-Term Safety and Efficacy in Hemophilia B Over 6 Years: Study Medha Baranwal23 April 2025 8:30 AM ISTAustralia: In a significant development for Hemophilia B treatment, a multi-year follow-up study has shown that a single infusion of fidanacogene...
FDA Approves fitusiran for Hemophilia A and B Dr. Kamal Kant Kohli2 April 2025 9:15 AM ISTThe FDA has approved fitusiran, now named Qfitlia, for routine prophylaxis in patients aged 12 and older with hemophilia A or B, with or without...
Novo Nordisk Gets CDSCO Panel Nod To Import, Market Concizumab Injection Dr. Divya Colin5 March 2025 6:00 PM ISTNew Delhi: Citing that there is unmet medical need in the country for the proposed indication, the Subject Expert Committee (SEC) functional under the...
Novo Nordisk bleeding disorder injection gets USFDA nod Ruchika Sharma21 Dec 2024 11:30 AM ISTPlainsboro: Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved Alhemo (concizumab-mtci) injection as a...
FDA Approves New treatment option for cutting bleeding in Hemophilia A or B Dr. Kamal Kant Kohli12 Oct 2024 11:00 AM ISTHemophilia A and hemophilia B are genetic bleeding disorders caused by a dysfunction or deficiency of coagulation factor VIII (FVIII) or IX (FIX),...
Single-dose gene therapy potentially life-changing for adults with hemophilia B: Study Dr. Kamal Kant Kohli26 Sept 2024 8:15 PM IST Adults with hemophilia B saw their number of bleeding episodes drop by an average of 71 percent after a single infusion of gene therapy,...
Pfizer gets European Commission conditional marketing nod for Durveqtix for Hemophilia B Ruchika Sharma28 July 2024 12:30 PM ISTNew York: Pfizer Inc. has announced that the European Commission (EC) has granted conditional marketing authorization for DURVEQTIX...
Labcorp gets USFDA nod for Companion Diagnostic for use with Pfizer hemophilia B Gene Therapy Ruchika Sharma2 May 2024 10:00 AM ISTBurlington: Labcorp has announced that the U.S. Food and Drug Administration (FDA) has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a...
USFDA nod to Pfizer Beqvez for adults with Hemophilia B Ruchika Sharma27 April 2024 12:09 PM ISTNew York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ (fidanacogene elaparvovec-dzkt) for the...
Pfizer gene therapy for bleeding disorder approved in Canada Ruchika Sharma4 Jan 2024 11:51 AM ISTCanada: Pfizer said on Wednesday that Canada's health regulator approved its gene therapy for the treatment of a rare inherited bleeding...
Pfizer application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec accepted by USFDA Ruchika Sharma28 Jun 2023 12:30 PM ISTNew York: Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application...
World's most expensive drug: USFDA nod to HEMGENIX worth USD 3.5 million a dose Roshni Dhar25 Nov 2022 5:41 PM ISTGlobal biotechnology leader CSL has announced that the U.S. Food and Drug Administration (USFDA) has approved HEMGENIX (etranacogene...
