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 ...
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 ...
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 ...
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 ...
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 ...
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 Food and Drug Administration has approved giving GSK's vaccine for respiratory syncytial virus down to age 50 years old, to those who are at higher risk of severe RSV, the company said Friday ...
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 ...
ChromaDex Corp. today announced that the U.S. Food & Drug Administration (FDA) granted Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) Designation for NRC, the company’s product ...
THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of ...