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Morning morning. Today, we learn the FDA is committing to CRL transparency, remember the impact of a gene therapy pioneer, and see positive LSD data for anxiety.
FDA makes good on pledge on drug rejection letters
The Food and Drug Administration is now publishing complete response letters to drugmakers shortly after they are issued, marking a major shift in transparency into regulation by the agency. Yesterday, the FDA disclosed 89 previously unreleased CRLs from 2024 and 2025, including rejections for Replimune, Capricor Therapeutics, and Ultragenyx.
Continue to STAT+ to read the full story…
