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 ...

The FDA outright refuses to review Moderna’s mRNA-based flu vaccine as CBER director Vinay Prasad’s conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have ...

Compass Pathways has reported another phase 3 win for its psilocybin therapy in treatment-resistant depression, sending the ...

Compass Pathways said on Tuesday its psilocybin-based therapy eased depression symptoms in a late-stage trial, sending the ...

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

Shares of at least four other developers were up by mid-single digits to low-double digits at certain points on Tuesday.

Compass Pathways on Tuesday disclosed results from two Phase 3 studies that support a potential approval of its psilocybin treatment for severe depression, but more detailed data are needed to ...

The latest readout, from the COMP006 study, showed that two doses of the highest, 25 mg dose of COMP360, given in a controlled environment with psychological support from a trained therapist, were ...

That didn’t take long. Moderna said this morning that the FDA will now review its experimental mRNA flu vaccine, reversing its decision denying a review because of a dispute over the vaccine’s ...

New subscription platform brings validated nonprofit data into one workspace to save time; expands discovery beyond ...