The company plans to meet with the FDA to discuss a rolling approval application for “COMP360,” a synthetic form of psilocybin that could become the first “classic” psychedelic cleared for the U.S.

Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the ...

The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; ...

Compass announced in January that the FDA had accepted its Investigational New Drug application for COMP360 for the treatment ...

Psychedelic drug developer Compass Pathways is preparing to talk to the FDA about filing its psilocybin therapy COMP360 for approval in treatment-resistant depression (TRD), after reporting positive ...