Supplemental Filings: FDA-CMS Collaboration, Beyfortus Approved For Pediatric RSV, Gavreto Loses An Indication, Sanders' Biosimilar Auto-Interchangeability Bill
Executive Summary
CDER Director Cavazzoni has her description of CMS’ mandate corrected, the FDA approves AstraZeneca/Sanofi's nirsevimab but requires safety studies on RSV variants, Genentech and Blueprint Medicines withdraw Gavreto's medullary thyroid cancer claim due to confirmatory trial feasibility issues, and Bernie Sanders goes bold on biosimilars.