The Food and Drug Administration approved Pfizer's treatment for a rare genetic bleeding disorder, making it the company's first gene therapy to win clearance in the U.S. The agency greenlighted ...
Pfizer won approval from the Food and Drug Administration for its first gene therapy, Beqvez, to be used by patients with the rare bleeding disorder, hemophilia B. The drug, a one-time treatment ...
The US Food and Drug Administration (FDA) has approved Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for hemophilia B. Developed by US pharma giant Pfizer (NYSE: PFE), Beqvez is authorized ...
(Adds price of rival therapy in paragraph 5, expert comment in paragraph 8) By Sriparna Roy April 26 (Reuters) - The U.S. Food and Drug Administration approved Pfizer's gene therapy for hemophilia B ...
A one-time dose of BEQVEZ has reduced bleeds post-treatment compared to standard of care with a median of zero bleeds (range 0 to 19) after up to three years of follow-up, providing sustained ...
Results from the nAbCyte test will indicate whether an individual can proceed with gene therapy. The US Food and Drug Administration (FDA) has approved the nAbCyte ™ Anti-AAVRh74var HB-FE assay as a ...
The US Food and Drug Administration (FDA) late yesterday approved Pfizer’s (NYSE: PFE) antibody drug conjugate Besponsa (inotuzumab ozogamicin) to include patients one year of age and older with ...
NEW YORK – The European Medicines Agency on Friday said its Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization in the EU to Pfizer's ...
Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median ...
Pfizer is preparing to launch its hemophilia B gene therapy Beqvez (fidanacogene elaparvovec-dzkt) after securing a U.S. approval for the treatment last month. Beqvez is the second gene therapy to be ...
The Food and Drug Administration (FDA) recently approved an expansion of a respiratory syncytial virus (RSV) vaccine for use in at-risk adults over the age of 50. GSK, the vaccine’s maker ...