FDA Novel Drug Approvals (Trailing 12 Months)

## What this measures

The number of novel drugs (new molecular entities and new therapeutic biologics) FDA's drug center approved in the 12 months ending with each month.

## Why it matters

Approvals arrive in bunches, often in December, so a rolling year shows the pace without waiting for the calendar year to close.

## How to read it

The highest reading is 61, reached in the 12 months to November 2018 and again in mid-2020. In the 12 months to September 2026 FDA approved 59.

## What it does not say

The count covers drugs reviewed by FDA's Center for Drug Evaluation and Research. Vaccines, blood products and cell and gene therapies, reviewed by the Center for Biologics Evaluation and Research, are not in it. A count says nothing about how important or how profitable the drugs are.

## 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.