According to the letter, the application could not be approved due to lack of substantial efficacy from the submitted studies. The Food and Drug Administration (FDA) has issued a Complete Response ...
Many people have interpreted as a setback the “no” vote by an advisory committee to the Food and Drug Administration on Lykos Therapeutics’ new drug application for MDMA-assisted psychotherapy for ...
These data represent one of the largest clinical development programs to date for adults living with PTSD and a significant development in a therapy area that hasn’t seen a new approval for a ...
LONDON & NEW YORK, January 07, 2026--(BUSINESS WIRE)--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today ...
MAPS Public Benefit Corporation (MAPS PBC), the nonprofit’s clinical-stage private arm, published new data from its second multi-site, ethno-racially diverse Phase 3 clinical study of MDMA-assisted ...
Compass Pathways has navigated to another successful midphase readout, linking its psilocybin therapy and psychological support to improvements in post-traumatic stress disorder (PTSD) in a small ...
A lab at the University of Idaho will use a Department of Defense grant to develop machine learning models that might be able ...