FDA to Review Biosimilar Hyrimoz High Concentration Formulation
The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF.
The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF.
A team of investigators evaluated the effects of concomitant use of PPIs and advanced therapy on health care resources in patients with IBD.
Normalization of 2 factors can foretell the potential for recurrence in patients who were in remission, according to a report.
Researchers evaluated the effects of antibiotic exposure, specifically cumulative use, timing of use, and the association with older-onset IBD.
Researchers compared the effectiveness of tofacitinib and vedolizumab among patients with UC who had experienced anti-TNF failure.
This slideshow shows drug information for the new ulcerative colitis indication for Rinvoq. Click here for the complete Rinvoq monograph.
The phase 3 ELEVATE 12 trial evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in 354 patients.
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.