Autoimmune diseases: 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.

New drug approvals

18 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
  • Avtozma (tocilizumab)

    Approved for: AVTOZMA ® (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) Adult patients with moderately to severel…

    BLA761498
  • Steqeyma (ustekinumab-stba)

    Approved for: 1. INDICATIONS AND USAGE STEQEYMA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who a…

    BLA761338
  • Pyzchiva (ustekinumab-ttwe)

    Approved for: USTEKINUMAB-TTWE is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for…

    BLA761373
  • Imuldosa (ustekinumab-srlf)

    Approved for: IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis in adults and pediatric patients 6 y…

    BLA761364
  • Ocrevus Zunovo (ocrelizumab and hyaluronidase)

    Approved for: OCREVUS ZUNOVO is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active seco…

    BLA761371
  • Selarsdi (ustekinumab-aekn)

    Approved for: Ustekinumab-aekn is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for…

    BLA761343
  • Tyenne (tocilizumab-aazg)

    Approved for: TYENNE ® (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) ( 1.1 ) • Adult patients with moderately to severe…

    BLA761275
  • Idacio (adalimumab-aacf)

    Approved for: IDACIO is a tumor necrosis factor (TNF) blocker indicated for: • Rheumatoid Arthritis (RA) ( 1.1 ): reducing signs and symptoms, inducing major clinical response, inhibiting the p…

    BLA761255
  • Wezlana (ustekinumab-auub)

    Approved for: WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older…

    BLA761285
  • Wezlana (ustekinumab-auub)

    Approved for: WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older…

    BLA761331
  • Omvoh (mirikizumab-mrkz)

    Approved for: OMVOH is indicated for the treatment of: moderately to severely active ulcerative colitis in adults. moderately to severely active Crohn's disease in adults. OMVOH TM is an interl…

    BLA761279
  • Zymfentra (infliximab-dyyb)

    Approved for: ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an i…

    BLA761358
  • Bimzelx (bimekizumab)

    Approved for: BIMZELX is a humanized interleukin-17A and F antagonist indicated for the treatment of: Moderate to severe plaque psoriasis (PSO) in adults who are candidates for systemic therapy…

    BLA761151
  • Velsipity (etrasimod)

    Approved for: VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults. VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated fo…

    NDA216956
  • Cosentyx (secukinumab)

    Approved for: COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are…

    BLA761349

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

7 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

472,802 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. 1Arthralgia30,876 reports
  2. 2Pain28,139 reports
  3. 3Fatigue26,408 reports
  4. 4Rheumatoid arthritis22,041 reports
  5. 5Psoriasis19,492 reports
  6. 6Headache19,318 reports
  7. 7Diarrhoea16,646 reports
  8. 8Crohn^s disease15,841 reports
  9. 9Nausea15,551 reports
  10. 10Covid-1915,426 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.

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