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.
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.
