Here We Go Again: US FDA Weighing Accelerated Approval For Biogen’s ALS Drug Tofersen
Company seeks accelerated approval based on changes in neurofilament as a surrogate for efficacy; with controversy over FDA’s Aduhelm approval in Alzheimer’s still raging, agency is again faced with deciding whether biomarker data in a neurodegenerative disease with high unmet need are sufficient to justify approval in the face of a failed clinical endpoint study.
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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 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.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker