FDA New Molecular Entity Approvals

This is a record of every genuinely new drug the FDA has approved since 1985. You'll find the drug name, what disease it treats, who made it, and when it got approved. The important part: it marks which drugs got special status. Some got 'priority review' (faster approval), some were for rare diseases (orphan drugs), some got 'breakthrough therapy' status because they looked really promising, and some got approved even faster than normal (accelerated approval). People use this data to answer the big question: do high drug prices actually fund real innovation, or is it just markup? By looking at what kinds of drugs got approved each year and which ones got special designations, you can see if the pipeline is actually producing breakthrough treatments or just minor variations on existing drugs.

Source rows:

1,387

Coverage:

1985-01-01T00:00:00Z – 2025-12-31T00:00:00Z