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10.22.2024

Drug approvals in 2024

Following is a list of drugs for neurologic conditions that have received approval from the U.S. Food and Drug Administration in 2024.

Alzheimer disease

KISUNLA (donanemab-azbt) injection
Approval granted: July 2, 2024
Indication: For the treatment of patients in the mild cognitive impairment or mild dementia stage of Alzheimer disease.
US FDA Press Release
Drug Trials Snapshot
Prescribing Information

Duchenne muscular dystrophy

DUVYZAT (givinostat)
Approval granted: March 21, 2024
Indication: For the treatment of Duchenne muscular dystrophy in patients 6 years of age and older
US FDA Press Release
Drug Trials Snapshot
Prescribing Information

Grade 2 astrocytoma or oligodendroglioma

VORANIGO® (vorasidenib) an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor
Approval granted: August 6, 2024
Indication: For the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) or
isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection.
US FDA Press Release
Prescribing Information

Niemann-Pick disease type C

AQNEURSA (levacetylleucine)
Approval granted: September 24, 2024
Indication: Treatment of neurologic symptoms associated with Niemann-Pick disease type C in adults and pediatric patients weighing at least 15 kg
US FDA Press Release
Prescribing Information

MIPLYFFA™ (arimoclomol)
Approval granted: September 20, 2024
Indication: For use in combination with miglustat for the treatment of neurologic manifestations of Niemann-Pick disease type C in adult and pediatric patients 2 years of age and older.
US FDA Press Release
Prescribing Information

Relapsed or refractory pediatric low-grade glioma

OJEMDA (tovorafenib) a kinase inhibitor
Approval granted: April 23, 2024
Indication: For the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or BRAF V600 mutation
US FDA Press Release
Drug Trials Snapshot
Prescribing Information

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