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.
Colorectal Disorders
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.
Zeposia Approved for Moderately to Severely Active Ulcerative Colitis
The FDA has approved Zeposia® (ozanimod) for moderately to severely active ulcerative colitis in adults.
- Loading...
Loading...
Next post in News
Loading... 
Loading...