Skyrizi Approved for Moderately to Severely Active Crohn Disease
The approval was based on data from two phase 3 induction studies, and one phase 3 maintenance study.
The approval was based on data from two phase 3 induction studies, and one phase 3 maintenance study.
Direct inhibition of STAT3 signaling by TTI-101 is expected to lead to reduced tumor growth.
The NDA submission is supported by data from the phase 2b trial evaluating futibatinib in adults with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements.
LUCENT-2 is a maintenance study evaluating the efficacy and safety of mirikizumab in patients who achieved clinical response in the 12-week LUCENT-1 induction study.
The application could not be approved in its present form due to manufacturing deficiencies.
Rivoceranib is an orally administered, small molecule inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2).
The designation is based on results from a phase 1 study that evaluated TT-00420 at different dose levels in 9 CCA patients.
The approval is supported by data from the phase 3 BEACON CRC trial in adults with BRAF V600E mutation-positive metastatic colorectal cancer with disease progression.
The application is supported by data from two phase 3 induction studies (ADVANCE and MOTIVATE) and one phase 3 maintenance study (FORTIFY).
The application is supported by data from the phase 3 RATIONALE 302 trial.