The European Commission has approved the Novartis agent Kymriah (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
FDA has been taking a look at psychedelics as a potential treatment for psychiatric and substance abuse disorders, recently publishing a final guidance for drug sponsors conducting clinical trials of psychedelics, including psilocybin, LSD, and MDMA.
