Premium Analysis: What FDA Approved in 2024, and Why the Mix Matters
FDA approved 50 novel drugs in 2024. Fifty-two percent were for rare diseases and 48% were first in class. What the mix says about where drug development is heading.
By Martin DAVILA1/20/20263 PremiumFDA's drug center approved 50 novel drugs in 2024. The headline count says little about which kind of drug is winning approval. The agency's own annual report does.
What kind of drugs did FDA approve?
More than half of FDA novel approvals in 2024 were for rare diseases, and almost half were first in their class.
CDER novel drug approvals in 2024, by category. A drug can be in both categories.
Source: US FDA, New Drug Therapy Approvals 2024. Orphan means a disease that affects fewer than 200,000 people in the US. First-in-class drugs act through a new mechanism.
View data
| group | count |
|---|---|
| Novel drugs approved | 50 |
| For rare diseases (orphan designation) | 26 |
| First-in-class | 24 |
Of the 50 novel drugs, 26 (52%) were approved for rare diseases and 24 (48%) were identified as first in class. FDA also approved a record 18 biosimilars in 2024, bringing its total since 2015 to more than 60.
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Sources
- US FDA, Advancing Health Through Innovation: New Drug Therapy Approvals 2024: 50 novel approvals, 26 with orphan designation (52%), 24 first-in-class (48%), 18 biosimilars.
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