Illustration of New Drug Application paperwork surrounded by pills, vials, and DNA. The US Food and Drug Administration approved 46 new molecular entities in 2025. Credit: C&EN/Shutterstock The year ...

How did staff layoffs, inspection backlogs and unprecedented leadership turnover affect the ability of the FDA to approve new drugs in 2025? While it would be presumptuous to base conclusions solely ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications. By the end of the ...

Drug developers secured approvals for 46 new therapeutic agents from the FDA’s Center for Drug Evaluation and Research (CDER) in 2025. This cohort brings the 5-year average down a touch, to 48 new ...

GoodRx has named 20 medications and vaccines as the most influential FDA approvals of 2025, spotlighting first-in-class drugs, new indications, and therapies with the potential to significantly affect ...

Below is a review of novel drug and biological products approved by the Food and Drug Administration (FDA) in 2025. The list includes several groundbreaking therapies that are expected to change the ...

The U.S. FDA approved 27 drugs in December, the highest month of 2025. This compares to 18 approvals in November and brings the full year total to 226. This places 2025 just below the 228 approvals ...

The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...

Domestic new drugs, which were released once or twice annually, have already received approval for two this year by April. This is attributed to the enhanced research and development (R&D) ...