In December 2025, Flow did in fact receive FDA Approval, based on data from the Empower trial. Before that, it had been marketed under FDA clearance—a lower evidentiary bar. That correction matters—and it sharpens the question many subscribers have been asking me: How much does FDA approval tell us about real‑world effectiveness?

Brexpiprazole’s uses are expanding beyond its original indications, with new research exploring its role in dementia and PTSD.

How a new FDA approved device for difficult-to-treat depression engages the brain through the sensory nerves in part II of our interview with Linda Carpenter.

We interview Linda Carpenter, lead investigator on the new FDA approved device for difficult-to-treat depression.

Should we follow the FDA and give SSRIs, or venture off-label with the fabled prazosin?

Did boundary violations sink MDMA-assisted therapy, or was there something more? In part II of our series, we look at what else went wrong.

Did boundary violations sink MDMA assisted psychotherapy? We explore the reasons behind the FDA panel’s rejection of this psychedelic therapy.