Ulcerative Colitis
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CLINICAL_TRIALS trial_result · 2023-09-29Clinical Trial Update: An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease [Phase 2]
An extension study (Phase 2) evaluating long-term safety and tolerability of UTTR1147A in moderate-to-severe Ulcerative Colitis or Crohn's D…
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CLINICAL_TRIALS trial_result · 2023-09-28Clinical Trial Update: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC) [Phase 3]
Phase 3 trial update for subcutaneous CT-P13 (infliximab) in moderately to severely active ulcerative colitis; study completed with results …
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FDA approval · 2023-09-27FDA Approved: ENTYVIO — Original Application (Takeda Pharmaceuticals America, Inc.)
ENTYVIO (vedolizumab) received FDA approval under the original application by Takeda Pharmaceuticals America for the treatment of adult pati…
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CLINICAL_TRIALS trial_result · 2023-09-26Clinical Trial Update: Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis [Phase 4]
A Phase 4 trial update on adherence of a 1,600 mg single-tablet 5-ASA treatment for Ulcerative Colitis.
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FDA approval · 2023-09-21FDA Approved: ADALIMUMAB — Supplemental Application (CELLTRION USA, Inc.)
FDA approved a supplemental Biologics License Application for the adalimumab biosimilar ADALIMUMAB-AATY from Celltrion USA, approving its bi…
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FDA approval · 2023-09-20FDA Approved: MESALAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for mesalamine by Teva Pharmaceuticals USA, Inc., marking an update to its labeling.
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FDA approval · 2023-09-12FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries Inc.)
FDA approved a supplemental application for mesalamine submitted by Sun Pharmaceutical Industries Inc.
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FDA approval · 2023-09-12FDA Approved: MESALAMINE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Mesalamine from Camber Pharmaceuticals, indicating an approved change to an existing generic pro…
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CLINICAL_TRIALS trial_result · 2023-09-07Clinical Trial Update: Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis [Phase 2]
Phase 2 trial update reporting efficacy and safety of orally administered BBT-401-1S in subjects with Ulcerative Colitis has completed with …
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CLINICAL_TRIALS trial_result · 2023-09-05Clinical Trial Update: A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) [Phase 2]
Phase 2 trial of LY3471851 in adults with moderately to severely active ulcerative colitis was terminated; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-09-05Clinical Trial Update: A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis [Phase 3]
Phase 3 study investigating SHR0302 for moderately to severely active ulcerative colitis; results and safety data are not yet disclosed.
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FDA approval · 2023-08-25FDA Approved: MESALAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for mesalamine from Sun Pharmaceutical Industries, updating the product labeling.
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FDA approval · 2023-08-24FDA Approved: SULFASALAZINE — Supplemental Application (Chartwell RX, LLC.)
FDA approved a supplemental application for the generic drug sulfasalazine submitted by Chartwell RX, LLC.
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FDA approval · 2023-08-08FDA Approved: BALSALAZIDE DISODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for balsalazide disodium from Hikma Pharmaceuticals USA Inc. under ANDA 077806, enabling continued m…
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FDA approval · 2023-08-07FDA Approved: MESALAMINE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Mesalamine (Actavis Pharma, Inc.), allowing continued marketing of Mesalamine products.
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FDA approval · 2023-08-07FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for mesalamine submitted by Zydus Lifesciences Limited.
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CLINICAL_TRIALS trial_result · 2023-08-01Clinical Trial Update: A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC) [Phase 2]
Phase 2 study of GB004 in adults with active ulcerative colitis was terminated; results posted.
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CLINICAL_TRIALS trial_result · 2023-07-21Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis [Phase 3]
Phase 3 trial update evaluating AJM300 in active ulcerative colitis has completed.
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CLINICAL_TRIALS trial_result · 2023-07-06Clinical Trial Update: Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC [Phase 2]
Phase 2 trial evaluating ALTB-168 for moderate to severe ulcerative colitis that is refractory to anti-TNF or anti-integrin therapy; study t…
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FDA approval · 2023-06-30FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
The FDA approved a supplemental application for the adalimumab biosimilar ADALIMUMAB-ADBM from Quallent Pharmaceuticals Health LLC.
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CLINICAL_TRIALS trial_result · 2023-06-18Clinical Trial Update: Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis [Phase 2]
Phase 2 clinical trial update for CU104 in moderate-severe ulcerative colitis.
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FDA approval · 2023-06-14FDA Approved: ABRILADA — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for ABRILADA (adalimumab-afzb) submitted by Pfizer Laboratories Div Pfizer Inc to update the labelin…
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FDA approval · 2023-06-08FDA Approved: BALSALAZIDE DISODIUM — Original Application (Zydus Lifesciences Limited)
FDA approves balsalazide disodium as a generic product under an original ANDA by Zydus Lifesciences Limited for the treatment of ulcerative …
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FDA approval · 2023-06-06FDA Approved: MESALAMINE — Original Application (Upsher-Smith Laboratories, LLC)
The FDA approved Upsher-Smith Laboratories, LLC's original application for mesalamine (a generic formulation).
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CLINICAL_TRIALS trial_result · 2023-05-31Clinical Trial Update: A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis [Phase 4]
Phase 4 randomized trial comparing early azathioprine plus infliximab to steroids plus azathioprine for acute severe ulcerative colitis has …