Crohn Disease
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Sign up freeTop drugs studied for this disease
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EMA approval · 2025-11-21EMA Authorised: Usgena (ustekinumab) — Stada Arzneimittel AG
The European Medicines Agency authorised Usgena, a ustekinumab product from STADA, for treatment of Crohn's disease, psoriasis, psoriatic ar…
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EMA approval · 2025-11-21EMA Authorised: Pyzchiva (ustekinumab) — Samsung Bioepis NL B.V.
EMA authorised Pyzchiva (ustekinumab) for Crohn's disease, ulcerative colitis, and psoriatic arthritis.
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FDA approval · 2025-11-20FDA Approved: IMULDOSA — Supplemental Application (Accord BioPharma Inc.)
FDA approved a supplemental application for IMULDOSA (USTEKINUMAB-SRLF) from Accord BioPharma Inc. The action updates the regulatory status …
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FDA approval · 2025-11-19FDA Approved: SELARSDI — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for SELARSDI (ustekinumab-aeKn) from Teva Pharmaceuticals USA, Inc. The product is a ustekinumab bio…
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FDA approval · 2025-11-18FDA Approved: USTEKINUMAB-TTWE — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for USTEKINUMAB-TTWE from Quallent Pharmaceuticals Health LLC.
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EMA approval · 2025-11-10EMA Authorised: Flixabi (infliximab) — Samsung Bioepis NL B.V.
The EMA authorised Flixabi, a biosimilar of infliximab, for several inflammatory diseases. The indications include rheumatoid arthritis, pso…
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FDA approval · 2025-11-03FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for Ustekinumab (Stelara) from Janssen Biotech, Inc., related to regulatory changes to its label…
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FDA approval · 2025-10-30FDA Approved: TYRUKO — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for TYRUKO (natalizumab-sztn) from Sandoz Inc. TYRUKO is a biosimilar to natalizumab (Tysabri) i…
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FDA approval · 2025-10-28FDA Approved: RENFLEXIS — Supplemental Application (Organon LLC)
FDA approved a supplemental application for RENFLEXIS (infliximab) submitted by Organon LLC. The approval updates the product labeling to re…
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EMA approval · 2025-10-22EMA Authorised: Amsparity (adalimumab) — Pfizer Europe MA EEIG
EMA authorised Amsparity (adalimumab) from Pfizer Europe MA EEIG. The biosimilar is approved for multiple autoimmune indications including r…
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EMA approval · 2025-10-21EMA Authorised: Idacio (adalimumab) — Fresenius Kabi Deutschland GmbH
EMA authorised Idacio, a biosimilar of adalimumab, for multiple inflammatory diseases, produced by Fresenius Kabi Deutschland GmbH. The indi…
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FDA approval · 2025-10-17FDA Approved: HADLIMA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for HADLIMA (adalimumab-bwwd) from Organon LLC, supporting expanded indications for this adalimumab …
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FDA approval · 2025-10-16FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)
FDA approved a supplemental application for Amjevita (adalimumab-atto) submitted by Nuvaila Limited.
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EMA approval · 2025-10-08EMA Authorised: Humira (adalimumab) — AbbVie Deutschland GmbH & Co. KG
The EMA authorised Humira (adalimumab) by AbbVie Deutschland GmbH & Co. KG for multiple indications including ankylosing spondylitis, juveni…
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FDA approval · 2025-09-17FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)
The FDA approved a supplemental BLA for AMJEVITA (adalimumab-atto) submitted by Nuvaila Limited. The action concerns regulatory approval rel…
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FDA approval · 2025-09-03FDA Approved: INFLECTRA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Inflectra (infliximab-dyyb) from Pfizer to update its labeling and/or indications, following…
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FDA approval · 2025-08-14FDA Approved: OTULFI — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for OTULFI (ustekinumab-AAUZ) from Fresenius Kabi USA, LLC.
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FDA approval · 2025-07-29FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for Sandoz Inc for the adalimumab biosimilar ADALIMUMAB-ADAZ, enabling its use with indications cons…
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FDA approval · 2025-07-01FDA Approved: MESALAMINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approves a supplemental application for Mesalamine from Alembic Pharmaceuticals Limited.
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FDA approval · 2025-06-26FDA Approved: MERCAPTOPURINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for mercaptopurine, enabling continued marketing of the generic p…
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EMA approval · 2025-06-24EMA Authorised: Zessly (infliximab) — Sandoz GmbH
EMA authorised Zessly (infliximab) from Sandoz GmbH as a biosimilar for treatment of several inflammatory diseases, including rheumatoid art…
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FDA approval · 2025-06-17FDA Approved: MESALAMINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for MESALAMINE from Actavis Pharma, Inc., resulting in approval of a supplemental to the approved ge…
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FDA approval · 2025-06-13FDA Approved: AZATHIOPRINE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for azathioprine from Ascend Laboratories, LLC.
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FDA approval · 2025-05-22FDA Approved: STARJEMZA — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved STARJEMZA (ustekinumab-hmny) from Hikma Pharmaceuticals USA Inc. as a biosimilar to ustekinumab, enabling marketing for the sam…
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FDA approval · 2025-04-30FDA Approved: USTEKINUMAB-TTWE — Original Application (Quallent Pharmaceuticals Health LLC)
FDA approves an original biologics license application for USTEKINUMAB-TTWE from Quallent Pharmaceuticals Health LLC.