Ulcerative Colitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2020-10-05Clinical Trial Update: Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [Phase 3]
Phase 3 trial evaluating efficacy and safety of adalimumab in pediatric patients with moderate to severe ulcerative colitis has completed wi…
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FDA approval · 2020-10-01FDA Approved: PENTASA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for PENTASA (mesalamine) submitted by Takeda Pharmaceuticals America, Inc., resulting in changes to …
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FDA approval · 2020-10-01FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc., resulting in updated labeling…
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FDA approval · 2020-10-01FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for mesalamine submitted by Teva Pharmaceuticals USA, Inc.
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FDA label_change · 2020-10-01FDA Approved: CANASA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental labeling/approval for CANASA (mesalamine) from Allergan, Inc.
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CLINICAL_TRIALS trial_result · 2020-09-18Clinical Trial Update: Induction of Immunity Against Streptococcus Pneumoniae in Adults With Inflammatory Bowel Disease [Phase 4]
Phase 4 trial update on inducing immunity against Streptococcus pneumoniae in adults with inflammatory bowel disease (including Crohn's dise…
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CLINICAL_TRIALS trial_result · 2020-09-03Clinical Trial Update: Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC [Phase 3]
A Phase 3 trial comparing vedolizumab monotherapy to combination therapy with tacrolimus in ulcerative colitis was terminated; results were …
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CLINICAL_TRIALS trial_result · 2020-09-02Clinical Trial Update: Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis [Phase 1, Phase 2]
Phase 1/2 clinical trial evaluating adipose mesenchymal stem cells for ulcerative colitis; current status unknown.
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CLINICAL_TRIALS trial_result · 2020-08-17Clinical Trial Update: (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis. [Phase 3]
Extension study of Budesonide MMX 6 mg for maintenance of remission in Ulcerative Colitis completed.
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CLINICAL_TRIALS trial_result · 2020-08-14Clinical Trial Update: A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M [Phase 2]
Phase 2a randomized trial of IBD98-M in ulcerative colitis completed with results posted in 2020.
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FDA approval · 2020-08-14FDA Approved: MESALAMINE — Original Application (Actavis Pharma, Inc.)
The FDA approved Actavis Pharma, Inc.'s original ANDA for mesalamine, a generic version of the anti-inflammatory drug used to treat ulcerati…
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CLINICAL_TRIALS trial_result · 2020-08-05Clinical Trial Update: A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease [Phase 1]
Phase I study of etrolizumab in pediatric patients with moderate-to-severe ulcerative colitis or Crohn's disease was terminated; results hav…
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CLINICAL_TRIALS trial_result · 2020-07-22Clinical Trial Update: Phase II Study of HMPL-004 in Patients With Ulcerative Colitis [Phase 2]
Phase II study of HMPL-004 in ulcerative colitis has completed; results posted.
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FDA approval · 2020-07-15FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for budesonide submitted by Padagis US LLC. The approval updates the labeling for budesonide under t…
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FDA approval · 2020-07-06FDA Approved: HULIO — Original Application (Biocon Biologics Inc)
FDA approved HULIO (adalimumab-fkjp) from Biocon Biologics Inc via an original Biologics License Application, a biosimilar to adalimumab. Th…
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FDA approval · 2020-06-26FDA Approved: LIALDA — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for LIALDA (mesalamine) from Takeda Pharmaceuticals America, Inc., indicating an approved change…
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CLINICAL_TRIALS trial_result · 2020-06-18Clinical Trial Update: To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis [Phase 3]
Phase 3 clinical trial evaluating FE 999315 in Japanese patients with mild to moderate active ulcerative colitis has completed.
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CLINICAL_TRIALS trial_result · 2020-06-12Clinical Trial Update: A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)
Clinical trial evaluating disease control, treatment patterns, burden of disease, and quality of life in moderate to severe inflammatory bow…
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CLINICAL_TRIALS trial_result · 2020-06-11Clinical Trial Update: GSK2982772 Study in Subjects With Ulcerative Colitis [Phase 2]
Phase 2 trial of GSK2982772 in ulcerative colitis completed; results posted in 2020.
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CLINICAL_TRIALS trial_result · 2020-06-09Clinical Trial Update: A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis [Phase 1]
Phase I study of CT-P13 subcutaneous in active Crohn's disease and ulcerative colitis has completed with results posted.
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FDA approval · 2020-05-29FDA Approved: MESALAMINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Mesalamine from Actavis Pharma, Inc. under ANDA203817, indicating an update for the generic prod…
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CLINICAL_TRIALS trial_result · 2020-05-29Clinical Trial Update: A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis [Phase 2]
Phase 2 study of mirikizumab in moderate to severe ulcerative colitis completed with results posted in 2020.
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FDA approval · 2020-05-19FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for Mesalamine from Zydus Lifesciences Limited.
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FDA label_change · 2020-05-19FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA has approved Sun Pharmaceutical's supplemental application for mesalamine, likely resulting in changes to the product labeling.
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FDA approval · 2020-04-07FDA Approved: MERCAPTOPURINE — Supplemental Application (Nova Laboratories, Ltd)
FDA approved a supplemental application for Mercaptopurine (Purixan) submitted by Nova Laboratories, Ltd.