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 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.

The closed-loop feature of the Inceptiv SCS senses neural responses and is able to automatically adjust stimulation in real time.

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.

The approval was based on data from an open-label clinical trial that included 33 virologically-suppressed pregnant adults.

Up to 40% of patients hospitalized with urinary tract infection unnecessarily receive extended-spectrum antibiotics.

Ninety-seven percent of patients were free from vaso-occlusive crises for at least 12 consecutive months.