Day: December 11, 2025

The FDA has released updated recommendations on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars. These clarifications are intended to support consistent, compliant communication practices across the sector. Stakeholders involved in regulatory affairs, medical affairs, and commercial operations will find the document particularly relevant. The U.S. Food and Drug Administration’s guidance, Promotional Labeling … Read more

A major shift is unfolding in the world of CAR-T-cell therapy, and it didn’t come through a formal FDA guidance or regulation. Instead, it arrived as a “perspective” article in a top medical journal, authored by the FDA’s CBER leadership. Beneath its calm academic tone lies a seismic message: the era of open-label CAR T … Read more