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, ...

HealthDay News — Semaglutide is associated with a significant reduction in airway exacerbations in patients with asthma or chronic obstructive pulmonary disease (COPD), according to a study presented ...

Phase 3 Emerge trial results show a single 100µg dose of lysergide ODT produced rapid, statistically significant, and durable improvements in depression scores through 12 weeks.

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

The FDA has granted Priority Review to the supplemental Biologics License Application for satralizumab for MOGAD, marking a potential first-in-class targeted treatment for this rare central nervous ...

HealthDay News — From 2019 to 2026, there was an increase in glucagon-like peptide-1 receptor agonist (GLP-1 RA) prescribing for children aged 8 to 11 years without diabetes but with obesity, ...

FDA grants Fast Track designation to pacritinib for VEXAS syndrome, providing a potential therapeutic option for a severe hemato-inflammatory condition with no current approved treatments.