Humira Approved for Pediatric Ulcerative Colitis
The pediatric approval was based on data from the multicenter, randomized, double-blind phase 3 ENVISION I study.
Gastroenterology
Amoxicillin-Clavulanate Effective for Outpatients With Diverticulitis
As effective as metronidazole with fluoroquinolone, with reduced risk for one-year Clostridioides difficile infection
Fecal Transplant May Counter Anti-PD-1 Resistance in Melanoma
FMT plus anti-PD-1 therapy may change gut microbiome and help overcome drug resistance in some patients with advanced melanoma
EndoClot PHS Approved to Control Bleeding During GI Procedures
EndoClot PHS is a single-use device consisting of a starch-based powder hemostat to control bleeding in the GI tract.
Proton Pump Inhibitor Use Linked to Asthma Risk in Children
Findings showed that children who were initiated on PPIs were 57% more likely to be diagnosed with asthma.
Upadacitinib Meets End Points in Ulcerative Colitis Trial
The U-ACCOMPLISH induction study evaluated the efficacy and safety of upadacitinib in 515 adults with moderate to severe ulcerative colitis.
Ozanimod Gets Priority Review for Ulcerative Colitis
The submission is supported by data from the True North trial that assessed ozanimod as an induction and maintenance therapy for adults with moderately to severely active UC who had an inadequate response to prior treatment.
Byfavo Now Available for Induction, Maintenance of Procedural Sedation
Byfavo, a Schedule IV controlled substance, is a rapid-acting, reversible benzodiazepine.
FDA to Review Odevixibat for Progressive Familial Intrahepatic Cholestasis
Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor.
Retifanlimab Under Review for Anal Squamous Cell Carcinoma
The BLA is supported by data from the POD1UM-202 trial that evaluated retifanlimab in 94 adults with locally advanced or metastatic SCAC who progressed after platinum-based chemotherapy.
