Clinical Research Focus. 50th Edition Clinical Research Focus featuring topical articles of interest to the clinical trial community. Explore the news of January 2026. Read more
rare disease day
Rare Disease Day 2026: A New Economic Reality for Pharma Ahead of Rare Disease Day on February 28, the industry has reason to reflect on a structural reality: rare diseases are no longer a peripheral segment of innovation. They are redefining the economics of pharmaceutical development.  In 2025, the FDA approved 46 new medicines through its Center for Drug Evaluation and Research. Half received orphan designation, meaning they target rare Read more
FDA Embraces the One Trial Era
FDA Signals Shift Toward a One-Trial Default for Drug Approval FDA outlines a move toward one pivotal trial supported by confirmatory evidence. What this means for sponsors and clinical strategy. Read more
FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy | Cromos Pharma
FDA Rejects Regenxbio’s Hunter Syndrome Gene Therapy: A Turning Point for the AAV Field? The recent FDA rejection of Regenxbio’s gene therapy for Hunter syndrome (MPS II) is more than a single company setback. It is a signal, and the gene therapy sector should take it seriously. Read more

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