Keeping Track: Cardio-Renal Drugs At Heart Of US FDA’s March Approval Binge

Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.

Keeping Track Feature image — The US FDA approved seven new molecular entities and novel biologics in March. • Source: Shutterstock

The US Food and Drug Administration approved seven of the nine novel agents with March user fee goal dates, almost tripling the number of new molecular entities and novel biologics approved in January and February 2024 combined.

The Center for Drug Evaluation and Research’s six novel agent approvals in March bring the center’s 2024 count to nine,...