Pfizer's groundbreaking $3.5 million gene therapy for Hemophilia B just got FDA approval. Here’s what it means for patients and the future of medicine

The gene therapy is the third such product approved by the US Food and Drug Administration (FDA), following the November 2022 approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec) – also for hemophilia B – and the July 2023 approval of BioMarin’s Roctavian (valoctocogene roxaparvovec) for hemophilia A.

Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained an FDA approval for the acquired treatment. | Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics,

The BEQVEZ gene therapy inserts a working copy of the Factor IX (FIX) gene that codes for a high-activity FIX variant.

Burlington: Labcorp has announced that the U.S. Food and Drug Administration (FDA) has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine

Labcorp's nAbCyte Assay has been approved by the FDA as a companion diagnostic for Pfizer's gene therapy in treating Hemophilia B patients.

The FDA approved its first gene therapy companion diagnostic test last June, developed through a collaboration between ARUP Laboatories and BioMarin, maker of the hemophilia A treatment Roctavian (valoctocogene roxaparvovec-rvox).

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the

Pharmaceutical giant Pfizer has received US approval for a gene therapy against a form of hemophilia, a rare and inherited blood clotting disorder, the company said Friday.