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Each year, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) evaluates and, as appropriate, approves many therapies for patients and consumers. CDER publishes an annual New Drug Therapy Approvals report to showcase these novel approvals and the regulatory tools used to streamline the review and approval process.
As in previous years’ reports, the 2024 New Drug Therapy Approvals report features drug approvals that CDER considers likely to have a significant impact on public health. The 2024 report includes approvals for therapies that collectively treat a wide range of conditions, including a first-in-class drug for schizophrenia, three novel antibiotics and new drugs for many types of cancer.
In 2024, CDER approved 50 new drugs that had active ingredients not previously approved by the FDA. These approvals included 26 new therapies that had previously received an orphan drug designation to prevent, diagnose or treat a rare disease or condition. This included several therapies for rare conditions with no previously approved treatment, such as Neimann-Pick disease type C and WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis).
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