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

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

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.

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

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

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.

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

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

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.

First treatment approved for Alexander disease; Hyrnuo and Etcamah are approved for lung cancer and breast cancer, ...