In the last year, the FDA has approved two new drugs for ALS, after a nearly 20-year drought of new options. The approvals followed intense lobbying by advocacy groups
Menendez single-handedly blocked a bipartisan effort to strengthen the law regulating foreign influence in Washington
But the agency appears unwilling to overlook the failed study results and missing information in Brainstorm’s submission, including key details on manufacturing and quality control needed to establish the product’s safety. ALS destroys nerve cells in the brain and spinal cord needed to walk, talk, swallow and — eventually — breathe. Most people die within three to five years of their first symptoms.
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