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 ...
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 ...
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 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 ...
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 ...
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 ...
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 ...
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.