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FDA

Industry

11 Aug 2026

Psychedelic Medicine Is Having an Identity Crisis — And That’s a Good Thing

For most of the last decade, the story of psychedelic medicine was a story about the trip itself. Guided sessions. Eyeshades and headphones. A therapist sitting with a patient for...

By Madison Roberts

Industry

28 Jul 2026

FDA’s New Psychedelic Guidance Signals a Maturing Industry. Now Comes the Hard Part.

For years, the psychedelic medicine industry has operated in largely uncharted regulatory territory. Companies developing psilocybin, LSD, MDMA, and next-generation psychedelic-inspired compounds have often found themselves navigating a clinical landscape...

By Madison Roberts

Events, Industry

13 Jul 2026

The Psychedelic Sector Has Grown Up. Wall Street Just Hasn’t Fully Realized It Yet

The sector experienced an early wave of enthusiasm fueled by bold promises, lofty valuations, and the belief that psychedelic medicine would quickly transform mental healthcare. Reality, however, proved more complicated....

By Madison Roberts

Breaking News

10 Sep 2024

Mindstate Design Labs AI-Designed Trial Gets FDA Approval

Mindstate Design Labs has announced major news, receiving both FDA and European Medicines Agency (EMA) approval to commence human trials of its compound, MSD-001. This approval is a clinical validation...

By Microdose NewsDesk

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Science

13 Oct 2023

FDA Issues Warning Letter for Ketamine

The FDA has issued a warning letter regarding the use of ketamine outside of FDA-approved conditions....

By Jason Najum

Industry

27 Sep 2023

FDA Accepts PharmaTher’s New Drug Application for KETARX™ (Ketamine)

The FDA has accepted the company’s Abbreviated New Drug Application for KETARX™ (racemic ketamine). The goal date for this priority original ANDA of April 29, 2024....

By Microdose NewsDesk

Industry

8 Aug 2023

Filament Health Announces FDA Approval of Two Clinical Trials

FDA has approved two clinical trials studying the effects of PEX010, Filament's botanical psilocybin drug candidate....

By Microdose NewsDesk

Industry

14 Jul 2023

Legal Psychedelics: Which Compounds Will Be Approved Next?

Which psychedelics will be next to be FDA approved? We take a closer look....

By Microdose NewsDesk

Law & Politics

1 Jul 2023

FDA Draft Guidance on Clinical Trials for Psychedelics: A Closer Look

This is the FDA’s first guidance focusing on psychedelic drug development. Phillips Lytle law firm takes a closer look....

By Phillips Lytle

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Professional Training in Psychedelic Medicine

Psychedelic medicine is reshaping the future of mental health care. From the power of microdosing LSD to the promise of MDMA in PTSD, the world of medical psychedelics offers transformative possibilities. Our comprehensive, CE-accredited course provides you with the knowledge and understanding you need to tap into this groundbreaking field.

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