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FDA Novel Drug Approvals
New drugs approved by the FDA’s drug center, trailing 12 months
Plays the chart through its history. Pauses are where the data set a record or moved most.
Continuation · the recent trend, flattening · 30 days
Dashed: the projection from the latest reading. Shaded: the range about two in three outcomes land in. A projection, not a promise.
Covers new molecular entities and new biologics approved by CDER; excludes vaccines and gene therapies.
The pace at which genuinely new medicines reach the U.S. market. The rolling total shows the trend without the year-end jumps of annual counts.
What this chart reads
- FDA Novel Drug Approvals (Trailing 12 Months)as “Novel approvals”latest 2026-09-01
Sources
FDA Novel Drug Approvals (Trailing 12 Months). Source: U.S. Food and Drug Administration: "Compilation of CDER NME and New Biologic Approvals 1985–2025" and the "Novel Drug Approvals" page for each later year. FDA website content is in the public domain.
Charts are drawn from Palanor's signal library and recomputed from source data on every view. Transformations (changes, indexing, year-on-year rates) are Palanor's.