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.