FDA final guidance on psychedelics opens the door to psycho-oncology…

FDA released final guidance for psychedelic drug trials (psilocybin, LSD, MDMA) in psychiatric and substance abuse disorders, permitting treatment without mandatory psychotherapy—a regulatory shift that opens psycho-oncology research pathways. If you're running psychedelic trials for cancer patients, you no longer need to build psychotherapy into your protocol—FDA just cut a regulatory cost and complexity barrier that was keeping smaller teams out. The door to psycho-oncology is now open; the question is which established oncology player moves first.