House ALS Bill Would Require US FDA ‘Action Plan’ – But Not Conditional Approval
US House of Representatives if moving forward with a bill to respond to advocacy from ALS patients for more attention from FDA. The bill focuses on planning and scientific support, not new pathways.
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ALS ‘Urgency’, US FDA Regulatory Environment Justify Filing NurOwn, BrainStorm Says
BrainStorm discovered a statistical error while preparing the stem cell therapy's BLA, and corrected data show a statistically significant treatment difference for a key secondary endpoint in less advanced ALS. However, the Phase III trial still failed its primary clinical efficacy endpoint.
Senate Budget Draft Would Be Less Generous To US FDA Than House For FY2023
Senate appropriations bill would take back some of increase House offered Center for Drug Evaluation and Research and other FDA programs, setting up negotiations as start of FY2023 nears.
Senate Budget Draft Would Be Less Generous To US FDA Than House For FY 2023
Senate appropriations bill would take back some of the increase the House offered the Center for Drug Evaluation and Research and other programs, setting up negotiations as next fiscal year nears.