RYBREVANT (amivantamab-vmjw) 2025 Label: What Changed, Why It Matters, and How to Apply It in Practice
Bottom line: In early 2025 the RYBREVANT label tightened safety language (notably infusion-related reactions, anaphylaxis placement, and venous thromboembolism management with lazertinib) and clarified dosing/administration details. Later in 2025, FDA accepted a supplement to update overall survival results from MARIPOSA, which will flow into Clinical Studies once the updated PI posts. Together, these moves round […]
Breaking News: FDA Expands IZERVAY™ Label for Long-Term Use in Geographic Atrophy Management
1. What’s New? The U.S. Food and Drug Administration has approved an expanded prescribing label for IZERVAY™, enabling unlimited duration dosing in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) Astellas Pharma US, Inc. | News Room. Previously, treatment duration was capped at 12 months. 2. Clinical Evidence Behind the Expansion This […]
FDA’s New RDEP Framework: A Regulatory Deep Dive
On September 3, 2025, the FDA formally launched the Rare Disease Evidence Principles (RDEP) program, aimed at creating a clearer, faster pathway for therapies targeting ultra-rare, genetically driven diseases affecting fewer than 1,000 people in the U.S. U.S. Food and Drug AdministrationReuterswww.hoganlovells.com. What the RDEP Is — and Isn’t RDEP does not change the statutory […]