Xeloda Labeling Updated Under FDA’s New Program for Older Oncology Drugs
Project Renewal is an Oncology Center of Excellence initiative that aims to update the labeling information for certain older oncology drugs.
Diagnosis & Disease Information
November 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in November 2022 for investigational products in development.
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.
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.
Konvomep Approved for Active Benign Gastric Ulcer, Upper GI Bleed Risk Reduction
Konvomep contains 2mg of omeprazole, a proton pump inhibitor, and 84mg of sodium bicarbonate per mL after reconstitution.
IBS-C Treatment Zelnorm Withdrawn From the Market Again
The decision to remove Zelnorm from the market was strictly a business decision.
Bevacizumab Biosimilar Alymsys Gets FDA Approval
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
Investigational Oral Therapy Fast Tracked for Familial Adenomatous Polyposis
Familial adenomatous polyposis is caused by abnormalities in the APC gene.
