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 ...
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 ...
Welcome to 2024's regulatory tracker for Fierce Pharma. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications.
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 ...
Geron's CEO said the company anticipates a peak market potential of $1.2 billion in the US and some key EU countries by 2030. In March, by a 12-to-2 margin, the FDA adcomm panel voted in favor of ...
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 ...