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 ...
Pfizer announced that the US Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt), a one-time gene therapy for adults with moderate to severe hemophilia B. The ...
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 ...
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe ...
The FDA on Friday gave its approval to Pfizer’s one-time gene therapy fidanacogene elaparvovec-dzkt, which will now carry the brand name Beqvez, for the treatment of moderate to severe hemophilia B in ...
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 ...
(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 ...
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 ...