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Psychedelics News

FDA

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

Breaking News

5 Jun 2024

FDA Advisory Committee Rejects Lykos’ MDMA Therapy For PTSD

An FDA advisory panel has rejected the approval of MDMA as a treatment for post-traumatic stress disorder (PTSD). The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) met to review Lykos Therapeutics’...

By Jason Najum

ketamine

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

FDA

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

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mushrooms decrim

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FDA Draft Guidance on Clinical Trials for Psychedelics: A Closer Look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

FDA psychedelics

Industry

23 Jun 2023

FDA Issues First Draft Guidance on Psychedelic Clinical Trials

The FDA has published new guidance for researchers investigating the use of psychedelic drugs for the treatment of medical conditions....

By Microdose NewsDesk

Law & Politics

10 Jun 2023

A Deeper Look at the Clinical Trial Process and FDA Approval of Psychedelics

An explainer to help you follow your favorite psychedelic medicine through the FDA and clinical trial process...

By Microdose

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