FDA approvals and recalls

Allergies: 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

  • Exdensur (depemokimab)

    Approved for: EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Lim…

    BLA761458

  • Rhapsido (remibrutinib)

    Approved for: RHAPSIDO ® is indicated for adult patients who remain symptomatic despite use of H1 antihistamine for the treatment of: chronic spontaneous urticaria. symptomatic dermographism. R…

    NDA218436

  • Ebglyss (lebrikizumab-lbkz)

    Approved for: EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is…

    BLA761306

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

Drug recalls

22 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

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

At the source

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

510(k) clearances

1 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

260,376 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. 1Pruritus40,098 reports
  2. 2Dermatitis atopic38,022 reports
  3. 3Rash21,900 reports
  4. 4Dry skin18,524 reports
  5. 5Injection site pain17,324 reports
  6. 6Eczema15,077 reports
  7. 7Skin exfoliation10,078 reports
  8. 8Urticaria9,708 reports
  9. 9Arthralgia9,160 reports
  10. 10Erythema8,450 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 allergies

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Chronic Urticaria Treatment

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