50 new drugs received FDA approval in 2024

The US Food and Drug Administration approved 50 new molecular entities in 2024—just five fewer than it did in 2023. Last year’s number of drug approvals is similar to what the agency achieved in other years in the 2020s, with the exception of 2022, when it approved just 37. The 28 small-molecule therapies approved last year account for 56% of new drugs, the same percentage of new small-molecule therapies approved in 2023. Antibody-based drugs were also plentiful; 13 of them were approved, which represents 26% of 2024’s new molecular entities, up from 22% in 2023.

C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research; therefore, it does not include blood products, gene therapies, vaccines, and other therapies that are approved by the FDA’s Center for Biologics Evaluation and Research.

Among 2024’s notable new drugs were three approvals for antibiotic therapies: Allecra Therapeutics’ Exblifep (cefepime and enmetazobactam), Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium), and Iterum Therapeutics’ Orlynvah (sulopenem etzadroxil and probenecid). Drugmakers have viewed this class of medicine as a risky investment in recent years.

People with hemophilia A or B got two new treatments: Pfizer’s Hympavzi (marstacimab) and Novo Nordisk’s Alhemo (concizumab). The FDA also gave its nod to Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride), the first new class of antischizophrenia drug to be approved in decades. Roughly one-third of last year’s new drugs were for oncology and hematology indications—perennially popular therapeutic areas.