FDA approves leucovorin to treat rare cerebral folate deficiency

The Food and Drug Administration has approved expanded use of leucovorin calcium tablets for treating cerebral folate ...

FDA approves GSK’s Wellcovorin for cerebral folate deficiency

FDA worked with GSK to update Wellcovorin labelling for safe, effective use in adult and paediatric CFD-FOLR1 patients.
Fierce Pharma

FDA approves leucovorin for ultrarare cerebral folate deficiency subset without clinical trial

About five months after U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. | About five months after U.S. Health Secretary Robert F. Kennedy Jr. touted leucovorin as “an ...
Healthline

FDA Doesn’t Endorse Leucovorin for Autism, OKs It for Rare Brain Disorder

The FDA declined to endorse leucovorin as a treatment for autism, but approved the drug to treat cerebral folate deficiency, ...
BioSpaceOpinion

What the Leucovorin Approval Signals—or Doesn’t—About the FDA’s Rare Disease Stance

Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label ...
Becker's Hospital Review

Clinicians divided amid growing demand for unproven autism drug

Clinicians divided amid growing demand for leucovorin autism drug as major medical groups advise caution over safety and efficacy.
MPR

Leucovorin Tablets Approved for Cerebral Folate Transport Deficiency

Cerebral folate deficiency is a rare neurological disorder characterized by a decrease in CSF folate levels, leading to developmental regression, seizures, movement disorders, and other neurological ...

FDA approves leucovorin as first drug for rare genetic disorder, after touting it as autism treatment

The move comes months after the Trump administration touted leucovorin as a potential therapy for a broader group of patients with autism symptoms.
The American Journal of Managed Care

Leucovorin Treatment Expansion for Autism Symptoms Under FDA Review

Leucovorin is being reviewed by the FDA for treating cerebral folate deficiency, which causes developmental delays and autism-like features in children. GSK aims to update leucovorin's label for CFD ...

Bait and Switch? RFK Jr.’s FDA Pivots on ‘Promising’ Autism Treatment Leucovorin

Six months ago, the federal government loudly proclaimed the likely benefits of an existing drug called leucovorin for treating autism. Now that proclamation has officially turned into a whimper. On ...
Healio

FDA approves leucovorin calcium for cerebral folate deficiency

The FDA has expanded its approval of leucovorin calcium tablets to treat cerebral folate deficiency in patients with a folate receptor 1 gene variant, according to a press release from the agency.