Crohn Disease
📧 Sign up to get email alerts when something new happens for Crohn Disease.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2023-11-08FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for CIMZIA (certolizumab pegol) from UCB, Inc., updating its labeling and/or indications.
-
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.
-
CLINICAL_TRIALS trial_result · 2023-11-07Clinical Trial Update: Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study [Phase 1, Phase 2]
Pilot study evaluating hyperbaric oxygen therapy for perianal fistulizing Crohn's disease not responding to conventional care; phase 1/2 wit…
-
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…
-
CLINICAL_TRIALS trial_result · 2023-11-01Clinical Trial Update: A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006) [Phase 2]
This document reports the results from a Phase 2a open-label safety and efficacy study of Tulisokibart (MK-7240/PRA023) in moderately to sev…
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
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.
-
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…
-
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.
-
CLINICAL_TRIALS trial_result · 2023-10-23Clinical Trial Update: CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD) [Phase 3]
Phase 3 trial evaluating subcutaneous CT-P13 (infliximab) for moderately to severely active Crohn's disease has completed with results poste…
-
CLINICAL_TRIALS trial_result · 2023-10-23Clinical Trial Update: Flagyl Microbiome in Crohn's Disease [Phase 4]
Phase 4 clinical trial update for Flagyl Microbiome in Crohn's Disease completed.
-
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…
-
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…
-
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.
-
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…
-
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…
-
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…
-
CLINICAL_TRIALS trial_result · 2023-09-13Clinical Trial Update: A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease [Phase 3]
A Phase 3 trial evaluating ustekinumab re-induction therapy in moderately to severely active Crohn's disease has completed, with results pos…
-
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.
-
CLINICAL_TRIALS trial_result · 2023-09-07Clinical Trial Update: A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery [Phase 2]
A Phase 2 trial of TAK-018 in preventing Crohn's disease recurrence after surgery was terminated, with results posted.
-
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.
-
FDA approval · 2023-08-24FDA Approved: TYRUKO — Original Application (Sandoz Inc)
FDA approved TYRUKO (natalizumab-sztn) from Sandoz Inc under an original Biologics License Application as a natalizumab biosimilar. The appr…
-
CLINICAL_TRIALS trial_result · 2023-08-14Clinical Trial Update: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy [Phase 2]
Phase 2 randomized trial of ABT-494 in moderately to severely active Crohn's disease completed; results posted.
-
CLINICAL_TRIALS trial_result · 2023-07-24Clinical Trial Update: SIIT Based on UST CDST in Patients With CD [Phase 4]
Phase 4 clinical trial update for SIIT based on UST CDST in Crohn's disease is listed with unknown status.
-
CLINICAL_TRIALS trial_result · 2023-07-19Clinical Trial Update: Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease [Phase 1, Phase 2]
Clinical trial update on ITF2357 for Crohn's disease, terminated after Phase 1/2; results posted but study ended.
-
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.