The FDA approved 46 new drugs in 2025 from its Center for Drug Evaluation and Research. 50% of these were orphan drugs, those made for rare diseases. Over 70% passed through one or more of the expedited pathways. It's not a symbolic figure, it's a warning that rare disease has come to the fore and is now the strategic focus of pharma R&D. More Info: https://clival.com/blog/the-new-era-of-rare-disease-drug-development-trends-to-watch