Orphan Drug Insights Journal

Stay ahead of industry news, regulatory policy shifts, and orphan drug designation strategies.

Only Orphans Cote breaks down what matters most to rare disease drug developers to help sponsors bring new therapies to patients faster.

FDA approval process overlaid over a medical provider in a pink shirt.
October 30, 2025
Learn the benefits of orphan drug designation, how market exclusivity works, and when to apply for faster approval and greater funding success.
October 2, 2025
FDA’s new Rare Disease Evidence Principles (RDEP): what this means for biotech sponsors and orphan drug developers seeking faster approvals.