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.
LB1148 is a broad-spectrum serine protease inhibitor designed to neutralize digestive enzymes and potentially reduce intestinal damage.
The designation is supported by data from the 12-week, randomized, double-blind phase 2 FILLMORE trial.
Positive topline results were announced from a phase 3 trial evaluating glepaglutide in patients with short bowel syndrome.
Vegzelma is a vascular endothelial growth factor inhibitor.
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
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.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small intestine.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
A significantly greater proportion of patients treated with upadacitinib 15mg and 30mg achieved clinical remission at week 52 compared with those receiving placebo.