Crohn Disease
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-06-26Clinical Trial Update: A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction [Phase 2]
A Phase 2 trial of Spesolimab in fibrostenotic Crohn's disease was terminated. Results from the terminated trial have been posted.
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CLINICAL_TRIALS trial_result · 2023-06-23Clinical Trial Update: A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study [Phase 4]
Phase 4 trial updating efficacy of early versus late use of vedolizumab in Crohn's disease has completed.
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CLINICAL_TRIALS research · 2023-06-15Clinical Trial Update: Value of Pharmacokinetic Assays in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease [Phase 4]
Phase 4 trial investigating the value of pharmacokinetic assays to predict induction and maintenance therapeutic response in Crohn's disease…
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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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CLINICAL_TRIALS trial_result · 2023-05-31Clinical Trial Update: Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab [Phase 4]
Clinical trial update reporting phase 4 study on early use of adalimumab for Crohn's disease.
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FDA approval · 2023-05-23FDA Approved: ADALIMUMAB — Original Application (CELLTRION USA, Inc.)
FDA approved ADALIMUMAB-AATY from CELLTRION USA, Inc. as a biosimilar to adalimumab under an Original Application for the same indications a…
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CLINICAL_TRIALS trial_result · 2023-05-23Clinical Trial Update: Safety and Efficacy of Artesunate & Curcumin in Crohn's Disease [Phase 2]
Phase 2 clinical trial evaluating safety and efficacy of artesunate combined with curcumin for Crohn's disease.
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FDA approval · 2023-05-18FDA Approved: ADALIMUMAB-ADBM — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)
FDA approved a supplemental application for ADALIMUMAB-ADBM, a biosimilar to adalimumab, from QUALLENT PHARMACEUTICALS HEALTH LLC.
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CLINICAL_TRIALS trial_result · 2023-05-09Clinical Trial Update: HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease [Phase 4]
A Phase 4 trial investigating the impact of HLADQA1*05 genotype on the efficacy of infliximab in Chinese patients with Crohn's disease; stat…
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CLINICAL_TRIALS trial_result · 2023-05-06Clinical Trial Update: SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
Clinical trial update for the SECURE Crohn's disease post-marketing registry has completed with posted results.
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FDA label_change · 2023-05-01FDA Approved: MESALAMINE — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for mesalamine submitted by Zydus Lifesciences Limited, typically indicating a labeling update o…
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FDA approval · 2023-04-14FDA Approved: ADALIMUMAB — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for adalimumab-adaz, a biosimilar to adalimumab, confirming its regulatory approval for use.
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CLINICAL_TRIALS trial_result · 2023-04-12Clinical Trial Update: Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy [Phase 3]
Phase 3 trial evaluating low-dose oral methotrexate combined with anti-TNF therapy in pediatric Crohn's disease; study completed with posted…
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FDA approval · 2023-04-11FDA Approved: TYSABRI — Supplemental Application (Biogen Inc.)
FDA approved Biogen's supplemental application for TYSABRI (natalizumab). The action updates the product labeling to reflect the requested c…
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CLINICAL_TRIALS trial_result · 2023-04-04Clinical Trial Update: The Effects of Intraoperative Esketamine on Postoperative Pain and Mood in Patients With Inflammatory Bowel Disease [Phase 4]
A Phase 4 trial assessed the effects of intraoperative esketamine on postoperative pain and mood in patients with Crohn's disease and depres…
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FDA approval · 2023-03-31FDA Approved: YUSIMRY — Supplemental Application (Coherus BioSciences Inc)
FDA approved a supplemental Biologics License Application for YUSIMRY (adalimumab-aqvh) by Coherus BioSciences, authorizing the biosimilar p…
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FDA approval · 2023-03-31FDA Approved: MESALAMINE — Original Application (Aurobindo Pharma Limited)
FDA approved the Original Application for Mesalamine from Aurobindo Pharma Limited (generic Mesalamine). Indications include inflammatory bo…
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CLINICAL_TRIALS trial_result · 2023-03-15Clinical Trial Update: A Phase II Study in Patients With Moderate to Severe Active Crohn's Disease [Phase 2]
Phase II study in patients with moderate to severe active Crohn's disease has completed.
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CLINICAL_TRIALS trial_result · 2023-03-13Clinical Trial Update: Efficacy and Safety of TD-1473 in Crohn's Disease [Phase 2]
Phase 2 trial update on TD-1473 for Crohn's disease, terminated with posted results.
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FDA approval · 2023-03-06FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for ustekinumab (Stelara) to expand its indications, as requested by Janssen Biotech, Inc.
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CLINICAL_TRIALS trial_result · 2023-03-01Clinical Trial Update: GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation ) [Phase 4]
Phase 4 trial update for an anti-TNF discontinuation strategy in Crohn's disease and inflammatory bowel disease (including ulcerative coliti…
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CLINICAL_TRIALS withdrawal · 2023-02-01Clinical Trial Update: The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer [Phase 3]
A Phase 3 trial evaluating topical mesalazine sustained-release tablets for Crohn's disease with oral ulcers has been withdrawn.
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CLINICAL_TRIALS trial_result · 2023-01-30Clinical Trial Update: A Phase 1/2 Study of Repeated Intravenous E6011 Administration in Japanese Subjects With Crohn's Disease [Phase 1, Phase 2]
Phase 1/2 trial summary for repeated IV administration of E6011 in Crohn's disease completed; results posted.
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FDA approval · 2023-01-25FDA Approved: ENTYVIO — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approves a supplemental application for ENTYVIO (vedolizumab) from Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2023-01-25Clinical Trial Update: National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
A national observational study assessing the real-world use of Inflectra (infliximab biosimilar) across multiple inflammatory diseases compl…