Phase 3 COVER DFUS II trial data show the autologous therapy plus standard of care significantly improves wound closure rates at 12 weeks.

The sNDA approval provides clinicians with the first FDA-cleared photodynamic therapy for skin cancer, backed by phase 3 trial data demonstrating superior clinical and histologic clearance.

SAMA and SABA + SAMA use associated with increased risk for heart failure, arrhythmia, and mortality versus no use ...

The application is supported by phase 2 APEX trial data, which demonstrated a 65% objective response rate among patients with advanced disease.

Progressive decrease in adjusted odds of hospitalization seen in association with vaccination versus no vaccination.

Labeling update reduces required post-infusion monitoring time for initial doses from 22 to 24 hours to 6 to 8 hours in patients with extensive-stage small cell lung cancer.

The FDA is reviewing an sNDA to extend the duration of use for the hormone-free Miudella intrauterine system from 3 years to up to 6 years.

The FDA has expanded the indication for leniolisib to include younger pediatric patients with activated phosphoinositide 3-kinase delta syndrome (APDS).

The NDA is supported by phase 3 LATITUDE data demonstrating rapid and durable skin clearance in adults with moderate to severe plaque psoriasis.

Courts are limiting the "error in judgment" defense: why diagnostic missteps do not qualify as acceptable clinical decision-making under the law.

Coverage with at least one Tdap dose and at least one MenACWY dose decreased from 2024 to 2025; HPV did not increase for fourth consecutive year.

In the phase 3 LUNA trial, atogepant demonstrated a significant reduction in migraine days during the perimenstrual period compared with placebo.