FDA approvals
FDA Novel Drug Approvals for 2025: Precision Therapies, Rare Diseases, and China’s Growing Footprint
As of September 30, 2025, the FDA has approved 32 novel drugs, emphasizing precision medicine, rare disease advances, and a notable increase in China-origin therapies gaining U.S. approval. This analysis covers key drugs, modalities, and the evolving China biotech footprint.