United States: Healthcare

On June 3, 2026, the U.S. Food and Drug Administration issued a new draft guidance titled Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (the 2026 Draft Payor Guidance).

A coalition of organ procurement organizations challenges a controversial CMS performance framework in federal court, but first must overcome a critical jurisdictional hurdle that could determine whether they can seek relief before facing potential decertification.

The European Medicines Agency has approved two ranibizumab biosimilars for treating macular degeneration, while Eli Lilly announced three major acquisitions to expand its infectious disease research. Meanwhile, regulatory approvals continue for biosimilar products including golimumab, denosumab, and insulin glargine, as the FDA issues new guidance on genome-editing safety standards for gene therapy development.