Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-12-05FDA Approved: PREDNISONE TABLETS, USP, 5 MG — Supplemental Application (Granulation Technology, Inc.)
FDA granted a supplemental approval for Prednisone Tablets, USP, 5 mg to authorize a granulation technology manufacturing change by Granulat…
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CLINICAL_TRIALS trial_result · 2023-12-05Clinical Trial Update: Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis [Phase 4]
A Phase 4 clinical trial update evaluating the efficacy of mesalazine combined with biologics for moderate to severe ulcerative colitis.
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FDA approval · 2023-11-30FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)
The FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, Inc., allowi…
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FDA approval · 2023-11-27FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for mesalamine from Zydus Lifesciences Limited, authorizing changes described in the submission.
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CLINICAL_TRIALS trial_result · 2023-11-18Clinical Trial Update: Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease [Phase 4]
Phase 4 extended access trial of vedolizumab IV in ulcerative colitis and Crohn's disease has been terminated with results posted.
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CLINICAL_TRIALS trial_result · 2023-11-09Clinical Trial Update: Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis [Phase 2]
Phase 2 study of LYS006 in mild to moderate ulcerative colitis was terminated; results were posted on 2023-11-09.
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FDA approval · 2023-11-07FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for Mesalamine from Zydus Lifesciences Limited, updating its labeling.
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FDA approval · 2023-11-03FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)
FDA approves a supplemental application for HUMIRA (adalimumab) to Cordavis Limited, enabling an additional manufacturing/supply pathway for…
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CLINICAL_TRIALS trial_result · 2023-11-02Clinical Trial Update: A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) [Phase 2]
A Phase 2 study evaluating the efficacy and safety of CBP-307 in adults with moderate to severe ulcerative colitis has completed. Results ha…
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FDA approval · 2023-10-31FDA Approved: WEZLANA — Original Application (Nuvaila Limited)
FDA approved WEZLANA (ustekinumab-auub) from Nuvaila Limited under an original Biologics License Application.
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FDA approval · 2023-10-31FDA Approved: WEZLANA — Original Application (Nuvaila Limited)
This entry documents the original Biologics License Application for WEZLANA, a ustekinumab-AUUB monoclonal antibody developed by Nuvaila Lim…
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CLINICAL_TRIALS trial_result · 2023-10-27Clinical Trial Update: A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) [Phase 2]
Phase 2 clinical trial update for mirikizumab in children and adolescents with ulcerative colitis, completed with results posted in 2023.
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FDA approval · 2023-10-26FDA Approved: OMVOH — Original Application (Eli Lilly and Company)
FDA approved OMVOH (mirikizumab-mrkz) from Eli Lilly through an Original Biologics License Application, authorizing its marketing. This is t…
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FDA approval · 2023-10-24FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for CANASA (mesalamine) submitted by Allergan, Inc.
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FDA approval · 2023-10-24FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc.
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FDA approval · 2023-10-24FDA Approved: DIPENTUM — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Dipentum (olsalazine sodium) submitted by Viatris Specialty LLC.
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FDA approval · 2023-10-24FDA Approved: MESALAMINE — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for Mesalamine from ANI Pharmaceuticals, Inc., resulting in updated labeling for the product.
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FDA approval · 2023-10-24FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves a supplemental application for mesalamine from Teva Pharmaceuticals USA, Inc.
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FDA approval · 2023-10-24FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Pentasa (mesalamine) from Takeda Pharmaceuticals America, Inc., enabling changes to its labe…
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CLINICAL_TRIALS trial_result · 2023-10-24Clinical Trial Update: Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management [Phase 2]
Phase 2 clinical trial update evaluating tofacitinib for hospitalized acute severe ulcerative colitis management.
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FDA approval · 2023-10-20FDA Approved: ZYMFENTRA — Original Application (CELLTRION USA Inc.)
FDA approved ZYMFENTRA (inflximab-dyyb) from Celltrion USA as a biosimilar to infliximab (Remicade), based on demonstration of biosimilarity…
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CLINICAL_TRIALS trial_result · 2023-10-16Clinical Trial Update: Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN) [Phase 3]
Phase 3 trial comparing oral etrasimod to placebo for moderately to severely active ulcerative colitis in adult Japanese participants has co…
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CLINICAL_TRIALS trial_result · 2023-10-16Clinical Trial Update: Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis [Phase 1, Phase 2]
Clinical trial update for fecal microbiota transplant in pediatric active ulcerative colitis and pediatric active Crohn's colitis (Phase 1/P…
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FDA approval · 2023-10-12FDA Approved: VELSIPITY — Original Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved VELSIPITY (etrasimod) from Pfizer as a new therapy for ulcerative colitis.
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CLINICAL_TRIALS trial_result · 2023-10-10Clinical Trial Update: High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade [Phase 3]
A Phase 3 trial evaluating high-dose interval vitamin D supplementation in patients with inflammatory bowel disease receiving Remicade.