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.
Pfizer gene therapy made in NC gets FDA approval. It costs $3.5M per dose
Pfizer's huge facility in Sanford produces its first FDA-approved gene therapy, which runs $3.5 million a dose.
GEN9d
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.
MedCity News12d
Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B
Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the ...
FiercePharma11d
Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose
Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained an ...
FierceBiotech8d
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 ...
Pfizer gets FDA approval for hemophilia B gene therapy Beqvez
Pfizer (PFE) said it has received FDA approval for its one-time gene therapy Beqvez for the treatment of certain adults with ...
pharmaphorum1h
Pfizer pauses DMD gene therapy trial after boy’s death
The death of a young boy with Duchenne muscular dystrophy (DMD) who was treated with Pfizer’s experimental gene therapy in a phase 2 trial has prompted the company to pause dosing in another study.
Medscape11d
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.
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 ...
Business Wire11d
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 ...
Yahoo11d
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 ...