FDA's Controversial Rejections: A Deep Dive

This chapter explores the unexpected rejection of Replimune's oncolytic virus therapy for advanced melanoma by the FDA, uncovering the complexities behind the drug review process. It highlights the internal dynamics at the FDA, the challenges faced by biotech companies, and the implications of leadership changes on drug approvals. Additionally, the chapter discusses Vertex's setbacks with their pain medication and the FDA's stringent requirements for expanding drug approvals.