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 · 2024-10-24FDA Approved: MESALAMINE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for mesalamine submitted by Ascend Laboratories, LLC.
-
FDA approval · 2024-10-10FDA Approved: IMULDOSA — Original Application (Accord BioPharma Inc.)
The FDA approves Imuldosa (ustekinumab-srlf) from Accord BioPharma Inc. under an Original Biologics License Application, expanding treatment…
-
FDA approval · 2024-09-27FDA Approved: OTULFI — Original Application (Fresenius Kabi USA, LLC)
FDA approved OTULFI (ustekinumab-aauz) from Fresenius Kabi USA, LLC, as an original application. OTULFI is a monoclonal antibody targeting I…
-
FDA approval · 2024-08-26FDA Approved: ADALIMUMAB-RYVK — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for ADALIMUMAB-RYVK, a biosimilar to adalimumab, submitted by Quallent Pharmaceuticals Health LL…
-
FDA approval · 2024-08-22FDA Approved: MESALAMINE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for mesalamine filed by Actavis Pharma, Inc., resulting in an approved updated label and/or form…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2024-08-22FDA Approved: MESALAMINE — Original Application (Ingenus Pharmaceuticals, LLC)
FDA approved Ingenus Pharmaceuticals, LLC's original application for mesalamine (generic mesalamine).
-
FDA approval · 2024-08-22FDA Approved: MESALAMINE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved mesalamine under an Original Application (ANDA) for Teva Pharmaceuticals, enabling marketing of a generic mesalamine product.
-
FDA approval · 2024-07-30FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved a supplemental application for MESALAMINE from ANI Pharmaceuticals, Inc.
-
FDA approval · 2024-07-30FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Dipentum (olsalazine sodium) submitted by Viatris Specialty LLC.
-
FDA approval · 2024-07-09FDA Approved: MERCAPTOPURINE — Supplemental Application (Nova Laboratories, Ltd)
The FDA approved a supplemental application for mercaptopurine (Purixan) by Nova Laboratories, Ltd., updating the product labeling and/or in…
-
FDA approval · 2024-07-09FDA Approved: MERCAPTOPURINE — Supplemental Application (Florida Pharmaceutical Products, LLC)
FDA approved a supplemental application for Mercaptopurine submitted by Florida Pharmaceutical Products, LLC.
-
FDA approval · 2024-06-28FDA Approved: USTEKINUMAB-TTWE — Original Application (Quallent Pharmaceuticals Health LLC)
FDA approves a new biologic product, ustekinumab-tTWE, from Quallent Pharmaceuticals Health LLC, via an Original Biologics License Applicati…
-
FDA approval · 2024-06-05FDA Approved: ZEPOSIA 7-DAY STARTER PACK — Supplemental Application (Celgene Corporation)
The FDA approved a supplemental application to authorize a Zeposia 7-day starter pack (ozanimod hydrochloride) from Celgene Corporation.
-
FDA approval · 2024-06-05FDA Approved: VELSIPITY — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved Pfizer's supplemental application for VELSIPITY (etrasimod), resulting in updated labeling and/or indication for ulcerative col…
-
FDA approval · 2024-05-23FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Mesalamine submitted by Zydus Lifesciences Limited.
-
FDA approval · 2024-05-14FDA Approved: XELJANZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for XELJANZ (tofacitinib) from Pfizer, granting an additional regulatory action under NDA 213082.
-
FDA approval · 2024-05-14FDA Approved: XELJANZ XR — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approves a supplemental application for XELJANZ XR (tofacitinib) from Pfizer, introducing the extended-release formulation. Submission s…
-
FDA approval · 2024-04-30FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for ABRILADA (adalimumab-afzb) from Pfizer Laboratories Div Pfizer Inc, authorizing its use as a…
-
FDA approval · 2024-04-26FDA Approved: RINVOQ — Original Application (AbbVie Inc.)
The FDA approved Rinvoq (upadacitinib) from AbbVie under an Original Application NDA, granting the drug its initial US marketing authorizati…
-
FDA approval · 2024-04-18FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Entyvio (vedolizumab) from Takeda Pharmaceuticals America, Inc., to modify labeling and expa…
-
FDA approval · 2024-04-18FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Entyvio (vedolizumab) from Takeda Pharmaceuticals America, resulting in a labeling update fo…
-
FDA approval · 2024-04-16FDA Approved: SELARSDI — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved SELARSDI (USTEKINUMAB-AEKN) from Teva Pharmaceuticals USA, Inc. under an original Biologics License Application (BLA 761343).
-
FDA approval · 2024-04-12FDA Approved: MESALAMINE — Supplemental Application (Encube Ethicals, Inc.)
FDA approved a supplemental application for Mesalamine from Encube Ethicals, Inc.
-
FDA approval · 2024-04-04FDA Approved: MESALAMINE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Mesalamine submitted by Ascend Laboratories, LLC.
-
FDA approval · 2024-04-01FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries Inc.)
FDA approves Sun Pharmaceutical Industries' supplemental application for Mesalamine, confirming regulatory approval for this generic product…