FDA reports decline in initial drug rejections, refutes claims of rising denials

The U.S. Food and Drug Administration announced that the number of drugs turned down after an initial review has fallen, contrary to recent speculation.

The agency said the notion that it is increasingly rejecting new medicines stems from a budget-related report released in 2027, which it described as inaccurate.

FDA officials emphasized that the decline reflects ongoing efforts to streamline the review process and urged industry and the public to rely on official data for an accurate picture of regulatory activity.