The US Food and Drug Administration approved 50 new molecular entities in 2024—just five fewer than it did in 2023.

 

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.

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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.

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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.

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Many medications were approved in 2024 — and more are on deck for 2025. Here’s a summary of 23 of the most notable approvals from the year.​