Experimental treatment pushed by ALS patients gets day before FDA, but agency unconvinced it works
The Food and Drug Administration meets this week to consider a much-debated treatment for Lou Gehrig’s disease. The deadly neurological disease has few treatment options. NurOwn, a stem cell therapy, is at the center of a yearslong lobbying campaign by patients seeking access to experimental medicines. But the FDA has repeatedly rebuffed drugmaker Brainstorm. The agency says the company's only study failed to show a benefit for patients. The review is the starkest test yet of FDA's commitment to “regulatory flexibility” to help patients with rare, deadly conditions. Advocates s...