Mid-Year Roundup: FDA’s Novel Retail and Specialty Drug Approvals in 2025

Each year, the FDA approves dozens of novel medicines, those that have never been approved or marketed in the United States. These drugs are critical to the impacted patient populations, who, before these approvals, often lacked a standard-of-care treatment option for their disease. Novel drugs are being developed at a rapid pace, expanding treatment capabilities for millions of patients. Accordingly, it is critical for patients and health care professionals alike to be aware of these novel drugs and their curative potential.¹