10 min read
10 Years of FDA Approvals: Six Designations, 459 Drugs
A decade of data. From Spinraza to Mounjaro, what the designations tell you.
We analyzed every novel drug the FDA approved from 2016 to 2025 - 459 drugs across 10 years - and tagged each one with its regulatory designations. Half target rare diseases. 42% are first-in-class. Breakthrough therapy doubled. From Spinraza to Mounjaro, the patterns tell you more about how the FDA works than any single approval ever could.