Crohn Disease

• EMA label_change · 2026-03-23
  EMA Authorised: Tremfya — Janssen-Cilag International NV

  EU authorises Tremfya to treat psoriasis, Crohn's disease, and ulcerative colitis.

• FDA label_change · 2025-06-27
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approves a supplemental application for Ustekinumab (Stelara) by Janssen Biotech, resulting in updated labeling.

• FDA label_change · 2023-05-01
  FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)

  The FDA approved a supplemental application for mesalamine submitted by Zydus Lifesciences Limited, typically indicating a labeling update o…

• FDA label_change · 2022-11-16
  FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for mesalamine from Teva Pharmaceuticals USA to update the product labeling.