WASHINGTON D.C. – The U.S. Food and Drug Administration (FDA) has initiated the process to approve leucovorin calcium tablets for treating cerebral folate deficiency (CFD). This neurological condition impairs the transport of folate to the brain. The FDA’s decision is based on a systematic analysis of scientific literature from 2009 to 2024, including case reports and other data, which demonstrate that leucovorin calcium can help individuals with CFD. Dr. Marty Makary, the FDA Commissioner, highlighted the agency’s commitment to finding and treating the root causes of autism, noting, “We have witnessed a tragic four-fold increase in autism over two decades. The agency remains dedicated to using “gold standard science and common sense to deliver for the American people.”