Center for Drug Evaluation and Research

Discovery of TL10:A Soluble and Long-Acting MC4RAgonist with Tunable Lipidation for Sustained Pharmacological Activity

Abstract The development of long-acting MC4R peptide agonists remains challenging due to rapid clearance and structural sensitivity, where conventional permanent lipidation strategies often impair receptor engagement. Here, we report the discovery and characterization of TL10, a...

Implementing the Zero Suicide Framework in a Statewide Youth Behavioral Health System: A Qualitative Study

Background The health-care system is an important point of intervention for youth suicide, and the Zero Suicide framework offers a comprehensive, evidence-informed approach to suicide prevention within health-care systems. Researchers evaluated implementation of the Zero Suicide...

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics

Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of...

FDA Approval Summary: Retifanlimab for the treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal

Abstract On May 15, 2025, the Food and Drug Administration approved retifanlimab in combination with carboplatin and paclitaxel for treating unresectable or metastatic squamous cell carcinoma of the anal canal (SCAC), and as a single agent for second-line SCAC treatment. These ap...