3 briefs
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.
A biosimilar approved in 2016. Still shelved in 2026.
Sandoz's Erelzi received FDA approval in August 2016. Nearly a decade later, it still hasn't launched in the US - while the same drug has been selling in Europe since 2017. The patent cliff is set for 2029. An antitrust challenge was dismissed in February 2026 and is now on appeal.
How to read a drug name you have never seen before.
Pembrolizumab. Adalimumab. Semaglutide. These look like random syllables. They're not. Every generic drug name follows a WHO naming code that encodes the drug class, mechanism, and modality directly into its name. Once you know the suffixes, you can decode any drug on sight.
Every drug has multiple stories. Most never get told. One brief every week. No spam.
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