Drug, Biologic Approvals Drop in 2025
With all the staffing turmoil FDA went through in 2025, drug and biologic approvals dropped below totals in the previous two years. A Fierce Pharma analysis finds that there were 46 novel drug approvals in 2025, compared to 55 in 2023 and 50 in 2024. In addition, there were 18 new biologic treatments approved in 2025, compared to 25 in 2023 and 18 in 2024.
The analysis says that in addition to the overall decline in approvals, there was a drop in the number of new drugs and biologics that are expected to generate blockbuster sales. It reports that in 2024, there were nearly 20 new products approved that were expected to deliver sales of at least $1 billion by 2030, according to Evaluate Pharma. For 2025, only eight newly approved medications carry those expectations.
Of the 46 novel drug approvals in 2025, 57% (26 products) were designated as rare disease orphan treatments.