FDA declines to approve Cingulate’s ADHD treatment over manufacturing issues 

 ADHD in the News 2026-06-04


June 2 (Reuters) - Drug developer Cingulate (CING.O), opens new tab said on ​Tuesday the U.S. Food and Drug Administration declined to approve its ‌treatment for attention deficit hyperactivity disorder, citing manufacturing-related concerns. In its complete response letter, the FDA did not flag any concerns about the drug's safety or effectiveness, Cingulate said.