In major shift, FDA to start releasing rejection letters shortly after they’re issued

The Food and Drug Administration said it would start releasing rejection letters soon after they are provided to drugmakers, a victory for those who wanted more transparency on what has been a hidden part of the drug review process. The agency also made public 89 of these complete response letters from 2024 and 2025 that had previously not been disclosed, including letters to Replimune, Capricor Therapeutics, and Ultragenyx, which have recently received rejections under the Trump administration. Advertisement “This is a milestone day for the agency,” FDA Commissioner Marty Makary said in a statement. “By embracing radical transparency — one of the guiding principles of this administration — we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust.”