FDA approvals fall but small pharma drives innovation, GlobalData finds

Drug approvals by the US Food and Drug Administration fell more than 15% in 2024, but smaller pharmaceutical companies are playing a bigger role in driving innovation, according to new analysis from data firm GlobalData.

The number of FDA approvals for innovator and biosimilar medicines dropped from 149 in 2023 to 126 last year, a decline of 15%. However, the report highlights that smaller players continue to push the industry forward, often addressing significant gaps in treatment and leaning on external expertise to scale up production.

Several smaller developers secured their first FDA approvals in 2024, including US biotech Madrigal Pharmaceuticals (Nasdaq: MDGL), whose drug Rezdiffra (resmetirom) became the first approved treatment for liver scarring caused by fatty liver disease. Another example is Verona Pharma (Nasdaq: VRNA), which won a green light for Ohtuvayre (ensifentrine) to treat adults with chronic obstructive pulmonary disease.