FDA approves Pfizer’s first gene therapy for rare inherited bleeding disorder
The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B.
GEN9 dienas
FDA Approves Pfizer’s One-Time Gene Therapy BEQVEZ for Hemophilia B
The BEQVEZ gene therapy inserts a working copy of the Factor IX (FIX) gene that codes for a high-activity FIX variant.
US FDA approves Pfizer's gene therapy for rare bleeding disorder
The U.S. Food and Drug Administration approved Pfizer's gene therapy for hemophilia B on Friday, the second such therapy for ...
Becker's Hospital Review9 dienas
FDA approves Pfizer's 1st gene therapy
Pfizer's first FDA-approved gene therapy is one of the most expensive medications in the U.S. On April 26, Beqvez (fidanacogene elaparvovec-dzkt) won approval to treat some adults with moderate-to ...
Yahoo11 dienas
FDA approves Pfizer's first gene therapy for rare inherited bleeding disorder
The Food and Drug Administration on Friday approved Pfizer’s treatment for a rare genetic bleeding disorder, making it the company’s first-ever gene therapy to win clearance in the U.S. The ...
Business Wire11 dienas
U.S. FDA Approves Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene ...
Pfizer gene therapy gets FDA OK
It fills me with great pride to announce that Pfizer received its first-ever FDA approval for a gene therapy, and now offers ...
The American Journal of Managed Care12 dienas
FDA Approves One-Time Gene Therapy Fidanacogene Elaparvovec for Hemophilia B
The FDA has approved fidanacogene elaparvovec-dzkt (Beqvez; Pfizer), a gene therapy administered in a one-time dose, for certain patients with moderate to severe hemophilia B. The FDA has approved ...
biopharma-reporter7 dienas
Pfizer heralds “paradigm shift” in hemophilia B gene therapy with FDA approval
Pfizer's groundbreaking $3.5 million gene therapy for Hemophilia B just got FDA approval. Here’s what it means for patients ...
Medscape11 dienas
FDA Approves Second Gene Therapy for Hemophilia B
Pfizer reported a list price of $3.5 million for its new gene therapy, Beqvez, for adults with this rare bleeding disorder.
FierceBiotech8 dienas
Labcorp nets companion diagnostic approval for Pfizer's hemophilia B gene therapy Beqvez
The FDA approved its first gene therapy companion diagnostic test last June, developed through a collaboration between ARUP ...