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 ...

Credit: Getty Images. Significant factors limit MDMA’s ability to be used in the treatment of post-traumatic stress disorder. Significant factors limit MDMA’s ability to be used in the treatment of ...

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 ...

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 ...

Myriam Barthes - Journey Clinical, Inc. Good day, ladies and gentlemen, and welcome to this COMPASS Pathways update webinar. [Operator Instructions] As a reminder, this call is being recorded. I would ...

FDA Accepts Investigational New Drug (IND) Application for COMP360 for the treatment of post-traumatic stress disorder (PTSD), enabling initiation of late-stage trial Compass continues to advance ...

Rena Goldman has over a decade of writing and editing experience. She covers health, wellness, mental health, small business, and how politics and policies impact our daily lives. Rena has worked as a ...