The New Era Of Rare Disease Drug Development: Trends To Watch

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.
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