FDA Panel Rejects Experimental ALS Cell Therapy
An FDA panel voted overwhelmingly against an experimental stem cell-based treatment for ALS, with experts stating that the drugmaker Brainstorm's therapy has not been proven effective for patients with the fatal disease. The FDA's negative review of the treatment aligns with the panel's vote, citing concerns about false hope and insufficient scientific evidence. ALS patients and advocates had sought access to the therapy, but the FDA emphasized the need for safety and efficacy in approving treatments for ALS and other hard-to-treat conditions. The FDA is expected to make a decision on the therapy by December 8.