Treatment for Accelerating Postop Bowel Function Gets Fast Track Status
LB1148 is a broad-spectrum serine protease inhibitor designed to neutralize digestive enzymes and potentially reduce intestinal damage.
Colorectal Disorders
Novel GI-Selective Therapy Gets Orphan Drug Designation for Pouchitis
The designation is supported by data from the 12-week, randomized, double-blind phase 2 FILLMORE trial.
Glepaglutide Reduces Need for Parenteral Support in Short Bowel Syndrome Trial
Positive topline results were announced from a phase 3 trial evaluating glepaglutide in patients with short bowel syndrome.
Bevacizumab Biosimilar Vegzelma Gets FDA Approval
Vegzelma is a vascular endothelial growth factor inhibitor.
Rinvoq Approved for Moderately to Severely Active Ulcerative Colitis
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
FDA to Review Abrilada for Interchangeability With Humira
The PAS is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis.
Yusimry, a Humira Biosimilar Product, Gets FDA Approval
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
FDA Clears System That Allows for Remote Endoscopy Procedures
PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small intestine.
First Interchangeable Biosimilar to Humira Gets FDA Approval
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
Upadacitinib Meets Endpoints in Ulcerative Colitis Maintenance Trial
A significantly greater proportion of patients treated with upadacitinib 15mg and 30mg achieved clinical remission at week 52 compared with those receiving placebo.
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