Ulcerative Colitis
📧 Sign up to get email alerts when something new happens for Ulcerative Colitis.
Sign up freeTop drugs studied for this disease
-
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.
-
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…
-
FDA approval · 2025-11-04FDA Approved: SULFASALAZINE — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original ANDA for sulfazalasine (sulfasalazine) manufactured by Rising Pharma Holdings, Inc.
-
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…
-
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…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
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…
-
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…
-
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 …
-
FDA approval · 2025-10-16FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for XELJANZ (tofacitinib) filed by Pfizer Laboratories Div Pfizer Inc, resulting in changes to t…
-
FDA approval · 2025-10-16FDA Approved: AMJEVITA — Supplemental Application (Nuvaila Limited)
FDA approved a supplemental application for Amjevita (adalimumab-atto) submitted by Nuvaila Limited.
-
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…
-
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…
-
EMA approval · 2025-09-12EMA Authorised: Velsipity (Etrasimod arginine) — Pfizer Europe MA EEIG
The European Medicines Agency authorised Velsipity (etrasimod arginine) by Pfizer Europe MA EEIG for the treatment of ulcerative colitis.
-
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…
-
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.
-
FDA approval · 2025-08-13FDA Approved: MESALAMINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved a generic mesalamine product after Camber Pharmaceuticals' Original Application (ANDA 219864).
-
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…
-
FDA approval · 2025-07-01FDA Approved: MESALAMINE — Supplemental Application (Alembic Pharmaceuticals Limited)
FDA approves a supplemental application for Mesalamine from Alembic Pharmaceuticals Limited.
-
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…
-
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…
-
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…
-
FDA approval · 2025-06-13FDA Approved: AZATHIOPRINE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for azathioprine from Ascend Laboratories, LLC.
-
FDA approval · 2025-05-29FDA Approved: MESALAMINE — Supplemental Application (Lannett Company Inc.)
FDA approved a supplemental application for Mesalamine (generic) from Lannett Company Inc., for the treatment of ulcerative colitis.
-
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…
-
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.