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 ...
The US Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay as a companion diagnostic to Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt). The assay ...
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 ...
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 bleed ...
Friday, the FDA approved Pfizer Inc’s (NYSE:PFE) Beqvez (fidanacogene elaparvovec-dzkt) for moderate to severe hemophilia B in adult patients who currently use factor IX (FIX) prophylaxis therapy or ...
(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 ...
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 ...
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 ...