Cases of ICP were reported in pregnant patients receiving azathioprine or 6-mercaptopurine to treat inflammatory bowel disease or systemic lupus erythematosus.
The phase 3 STRIDE-10 trial evaluated the safety and immunogenicity of V116 in pneumococcal vaccine-naive adults 50 years of age and older.
The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for tapinarof cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. Tapinarof is an aryl hydrocarbon receptor agonist currently marketed under the brand name Vtama® for the topical treatment of…
The nAbCyte cell-based neutralizing antibody assay detects AAVRh74var pre-existing neutralizing antibodies, which could impact patient safety and/or efficacy with Beqvez.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 4WHILM trial.
The approval was based on safety and efficacy data from clinical trials evaluating diazepam rectal gel, as well as adult bioavailability studies comparing Libervant with diazepam rectal gel, adult and pediatric pharmacokinetic data, and an open-label safety study of Libervant.
The approval of Hercessi was based on a comprehensive package of analytical, preclinical, and clinical data demonstrating that the biosimilar product is highly similar to the reference product, Herceptin.
Beqvez is a one-time AAV-based gene therapy designed to introduce in the transduced cells a functional copy of the FIX gene encoding a high-activity FIX variant.
CTX-009 is a bispecific antibody that simultaneously blocks Delta-like ligand 4 and vascular endothelial growth factor A.
Compared with dupilumab, a significantly higher proportion of patients treated with upadacitinib achieved both EASI 90 and a Worst Pruritus Numerical Rating Scale of 0 or 1.
