Cold Agglutinin Disease

• EMA approval · 2025-08-01
  EMA Authorised: Enjaymo (sutimlimab) — Recordati Rare Diseases

  EMA authorised Enjaymo (sutimlimab) for the treatment of cold agglutinin disease (autoimmune hemolytic anemia), with orphan medicine designa…

• FDA approval · 2024-02-08
  FDA Approved: ENJAYMO — Supplemental Application (Recordati Rare Diseases, Inc.)

  The FDA approved a supplemental application for ENJAYMO (sutimlimab-jome) submitted by Recordati Rare Diseases, Inc.

• FDA approval · 2023-01-25
  FDA Approved: ENJAYMO — Supplemental Application (Recordati Rare Diseases, Inc.)

  FDA approved a supplemental application for ENJAYMO (sutimlimab-jome) from Recordati Rare Diseases, Inc.

• FDA approval · 2022-09-23
  FDA Approved: ENJAYMO — Supplemental Application (Recordati Rare Diseases, Inc.)

  FDA approved a supplemental application for ENJAYMO (sutimlimab-jome) filed by Recordati Rare Diseases, Inc., approving changes described in…

• FDA approval · 2022-02-04
  FDA Approved: ENJAYMO — Original Application (Recordati Rare Diseases, Inc.)

  FDA approved ENJAYMO (sutimlimab-jome) for adults with cold agglutinin disease, marking the original approval for this therapy. The drug inh…

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