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FDA · United StatesLast August, Lykos Therapeutics announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) to its new drug application (NDA) that sought to have MDMA-assisted therapy approved for PTSD. In real terms, the agency had rejected Lykos’ first shot at getting the drug approved. After a period of intense reporting last year, we shifted focus to what the future… SourceSee the Story
One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect - Psychedelic Alpha

From Huxley to Heffter: Mark Geyer Reflects on a Life in Psychedelic Research - Psychedelic Alpha

United Kingdom · United KingdomEach quarter, we provide a look at federal lobbying disclosures by psychedelic drug developers and nonprofits. That data is a lagging indicator, especially as filings are not required immediately at the end of each quarter. Here’s a review of Q2 2025 activity… Psychedelic drug developers’ spend on federal lobbying in Q2’25 looked very similar to that seen in the first quarter… SourceRead Article