First Imaging Agent For Brain Tumor Surgery Gets US FDA Panel Backing
Advisory committee votes for approval of 5-ALA for real time detection and visualization of malignant tissue during glioma surgery; data shows improvement in tumor resection, but not on survival metrics.
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The latest drug development news and highlights from our US FDA Performance Tracker.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.
The agency's "Bad Ad" program issued a warning letter that claims the promotion for CooperSurgical's copper-containing intrauterine contraceptive lacked any safety information.