First-in-Class Drugs CDER identified 24 of the 50 novel drugs approved (48%) in 2024 as first-in-class.

CDER identified 27 of the 50 novel drugs approved in 2021 (54%) as first-in-class. These drugs have mechanisms of action different from those of existing therapies.

CDER identified 20 of the 55 novel drugs approved (36%) in 2023 as first-in-class. These drugs have mechanisms of action different from those of existing therapies.

CDER identified 20 of the 46 novel drugs approved (43%) in 2025 as first-in-class. These drugs have mechanisms of action different from those of existing therapies.

Jan 20, 2023 · In 2022, FDA approved new therapies to treat HIV infection, vulvovaginal yeast infection, and Helicobacter pylori infection (See Table 3).3 Two were first-in-class approvals (Sunlenca...

Jan 10, 2023 · CDER identified 20 of the 37 (54%) novel drugs approved in 2022 as first-in-class.

CDER identified 20 of the 48 novel drugs approved in 2019 (42%) as first-in-class, which is one indicator of the drug’s potential for strong positive impact on the health of the...