FDA Publishes New Drug Rejection Letters

Sep 6th 2025 4:40pm EDT

The FDA has released another batch of drug rejection letters, following up on the 200 complete response letters (CRLs) made public earlier this summer. The newly disclosed documents, spanning 2024 and 2025, shed light on the agency’s reasoning behind several high-profile rejections, from psychedelic therapies to ultra-rare disease treatments. The FDA said it will now […]

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