In the INTEGUMENT-INFANT trial, 34.4% of patients achieved vIGA-AD success and 58.3% reached EASI-75 at week 4.

Supported by WILLOW trial findings, the oral TLR 7/8 inhibitor demonstrated significant, dose-dependent reductions in skin disease activity for patients with lupus.

The US launch of Xtoro introduces a novel fluoroquinolone targeting key pathogens in acute otitis externa, delivering rapid ear pain cessation and high clinical cure rates.

Backed by phase 3 RINGSIDE data showing an 84% reduction in the risk of disease progression or death, the investigational agent moves ahead in the regulatory pipeline.

Researchers found that 140 individuals (32.1%) reported lifetime GLP-1 RA use and 96 (22.0%) reported current use. HealthDay ...

New 26-week data from the phase 3 COMP006 study validate the long-term durability, safety, and remission potential of a 2-dose COMP360 psilocybin regimen for highly chronic, treatment-resistant ...

A Prescription Drug User Fee Act target date of November 1, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug ...

Credit: Vera Therapeutics. Trutakna is supplied as a 150mg/mL single-dose prefilled autoinjector. Trutakna (atacicept-vymj), a first-in-class dual BAFF and APRIL inhibitor, secured FDA accelerated ...

High-dose docosahexaenoic acid (DHA) supplementation does not yield a change in brain volume or cognitive performance over 24 months, according to a study publi ...

The 12-month wind-down for therapeutics and 180-day transition for medical devices signal a definitive shift back to standard regulatory pathways, forcing manufacturers like Invivyd to pursue full FDA ...

A PDUFA target date of April 24, 2027 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ReNu ®, a ...