BioCentury
DATA GRAPHICS | Data Byte

FDA approved three new drugs in April

Total CDER approvals stand at 10 so far this year, 50% less than at this time last year

May 7, 2025 1:13 AM UTC

FDA approved just three NMEs in April, bringing the total for the first four months of the year to 10.

BioCentury also noted a slow start last year when only three NMEs had been approved by mid-March; however, a flurry of activity in the following six weeks brought the total to 15 approvals by the end of April, 50% more than 2025’s current count. Last year closed with 50 approvals, the fifth time the agency hit that number since 2018...

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