IBS-C Treatment Zelnorm Withdrawn From the Market Again
The decision to remove Zelnorm from the market was strictly a business decision.
Colorectal Disorders
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.
Improvements in Clinical Remission Seen With Etrasimod in UC Trial
The phase 3 ELEVATE 12 trial evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in 354 patients.
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.
ACP Issues 2 Guidelines for Acute Left-Sided Colonic Diverticulitis
Guidelines address diagnosis and management, use of diagnostic colonoscopy in complicated disease, and interventions to prevent recurrence
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.
