Precision Medicine Drug Approvals in 2024: New Drugs and Expanded Indications

Source: FDA databases, company announcements Does not include conversions from accelerated to full approval of the same indication. Precision Medicine Online tracks FDA approvals for three types of drugs: therapies approved for biomarker-defined populations; n-of-1 treatments, such as autologous CAR T-cell therapies; and therapies that replace, correct, or attenuate a genetic abnormality involved in the pathophysiology of a disease. This list contains FDA approvals of new molecular entities and expanded or amended indications of already marketed drugs based on FDA databases and company documents. Drugs that the FDA has converted to regular approval for the exact indication it previously granted accelerated approval are not on this list. However, if in converting an accelerated approval to a regular approval, the FDA amends or expands the indication for the treatment, we list those.
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