The agency greenlit the drug, which will be marketed as Beqvez, for adults with moderate to severe hemophilia B.
Pfizer's huge facility in Sanford produces its first FDA-approved gene therapy, which runs $3.5 million a dose.
The BEQVEZ gene therapy inserts a working copy of the Factor IX (FIX) gene that codes for a high-activity FIX variant.
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 ...
Ten years after dipping its toe into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained an ...
The FDA approved its first gene therapy companion diagnostic test last June, developed through a collaboration between ARUP ...
Pfizer (PFE) said it has received FDA approval for its one-time gene therapy Beqvez for the treatment of certain adults with ...
Pfizer reported a list price of $3.5 million for its new gene therapy, Beqvez, for adults with this rare bleeding disorder.
Pfizer said the patient, a young boy who was treated earlier last year, had died suddenly. The company is working with trial researchers to investigate further.
The U.S. Food and Drug Administration approved Pfizer's gene therapy for hemophilia B on Friday, the second such therapy for ...
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene ...
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 ...