FDA approvals and recalls

Brain and nerves: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

New drug approvals

3 new medicines approved (since 1 Jan 2023). Medicines with a new active ingredient that the FDA approved, whose label lists a use on this topic.

At the source

  • Avlayah (tividenofusp alfa-eknm)

    Approved for: AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pedi…

    BLA761485

  • Aqneursa (levacetylleucine)

    Approved for: AQNEURSA is indicated for the treatment of: • neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15 kg. ( 1.1 ) • ataxia i…

    NDA219132

  • Miplyffa (arimoclomol citrate)

    Approved for: MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2…

    NDA214927

Source: openFDA, Novel drug approvals (new molecular entities and new biologics), since 1 Jan 2023. Retrieved 12 Nov 2026.

Drug recalls

17 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

246 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Implant, Cochlear

    Reason: Due to a manufacturing deviation of incomplete electrode welds of cochlear implants and resulting in one or more open circuits

    Z-0349-2027

  • Neurological Stereotaxic Instrument

    Reason: Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient.

    Z-0314-2027

  • Neurological Tray

    Reason: Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

    Z-0177-2027

  • Neurological Stereotaxic Instrument

    Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

    Z-0194-2027

  • Neurological Stereotaxic Instrument

    Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

    Z-0195-2027

  • Neurological Stereotaxic Instrument

    Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

    Z-0196-2027

  • Neurological Stereotaxic Instrument

    Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

    Z-0197-2027

  • Neurological Tray

    Reason: Product may be potentially contaminated with a lubricant used during the manufacturing process.

    Z-0096-2027

  • Custom Anesthesia Tray

    Reason: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

    Z-3152-2026

  • Neurological Tray

    Reason: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical inte…

    Z-3268-2026

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

84 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

34,246 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Seizure5,552 reports
  2. 2Fatigue1,537 reports
  3. 3Hospitalisation1,432 reports
  4. 4Epilepsy1,393 reports
  5. 5Somnolence1,311 reports
  6. 6Nausea1,041 reports
  7. 7Vomiting920 reports
  8. 8Maternal exposure during pregnancy918 reports
  9. 9Dizziness890 reports
  10. 10Headache853 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Market reports on brain and nerves

Search all
Pharmaceuticals

ALS Treatment

Worldwide · 2024–2034

View report Pharmaceuticals

Alzheimer Drugs

Worldwide · 2024–2034

View report Medical Devices

Alzheimer's Blood Tests

Worldwide · 2024–2034

View report Pharmaceuticals

Alzheimer's Disease Drugs

Worldwide · 2024–2034

View report Healthcare Services

Alzheimers Dignostic

Worldwide · 2024–2034

View report Pharmaceuticals

Amyloidosis Treatment

Worldwide · 2024–2034

View report

From our blog

All stories

Brain Cancer Diagnosis: Imaging and New Biomarkers

About 321,000 people were diagnosed with brain and nervous system tumours in 2022, and about 248,000 died…

Read

Alzheimer's Diagnosis: Blood Tests and Earlier Answers

57 million people live with dementia. In May 2025 the US FDA cleared the first blood test used to help…

Read

Cannabis-Based Medicines: Science and Regulation

The FDA has approved one cannabis-derived medicine, Epidiolex, for rare epilepsies, and three synthetic…

Read

FDA approvals and recalls on related topics

All topics

Acuitas market sizes and forecasts are only in our full reports. How we use public data.