Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
Understanding the Guidance: What, Why, How In September 2025, the U.S. Food and Drug Administration (FDA) issued a nonbinding guidance for industry titled “Development…
Read more →FDA’s Guidance on Alternative Tools for Assessing Drug Manufacturing Facilities: What It Means for Pharma
In September 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance document titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in…
Read more →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…
Read more →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…
Read more →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…
Read more →EPYSQLI® (Eculizumab-aagh) — A Landmark Biosimilar in Rare Disease Treatment
Introduction Samsung Bioepis’ EPYSQLI® (eculizumab-aagh) has earned FDA approval as a biosimilar to Soliris® (eculizumab). Approved on July 19, 2024, EPYSQLI offers a more…
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