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September 2025

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FDA moves to approve Leucovorin Calcium for rare neurological disorder linked to Autism

The U.S. Food and Drug Administration (FDA) has taken a significant step forward in approving leucovorin calcium tablets for the treatment of cerebral folate deficiency (CFD) — a rare neurological condition that disrupts the transport of folate, a vitamin essential for brain development and function.

Cerebral folate deficiency has been associated with developmental delays, seizures, coordination problems, and autistic features such as challenges in social communication, sensory issues, and repetitive behaviors.

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