The US Food and Drug Administration (FDA) has approved the gene therapy fidanacogene elaparvovec (Beqvez) for adults with hemophilia B, a rare bleeding disorder that affects […]
Image By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Hilary Marston, M.D., M.P.H., Chief Medical Officer The Biologics Price Competition and Innovation […]
TOPLINE: Findings from an echocardiographic study of patients with heart failure with preserved or mildly reduced ejection fraction treated with an atrial shunt have shed more […]
TOPLINE: In patients with non–small cell lung cancer (NSCLC) who have metastases to the brain only, definitive treatment to the primary site improved overall survival outcomes […]
Docket Number: FDA-2024-D-1461 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]
TOPLINE: Delta wave activity disruption during sleep may be a useful metric to identify those at an increased risk for cardiovascular disease and cardiovascular mortality. METHODOLOGY: […]
Latest Update Clozapine Risk Evaluation and Mitigation Strategy (REMS) Advisory Committee Meeting 2024 April 25, 2024 – FDA will be hosting an in-person advisory committee meeting […]
DENVER — After working for decades in a field littered with promising but failed clinical trials, a prominent researcher in amyotrophic lateral sclerosis (ALS) has decided […]
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