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The Latest Breaking News from Lykos

RFK Jr will cut prescription drugs and increase weed and psychedelics access

Trump’s health department pick has expressed distrust of pharmaceuticals and attacked ‘suppression of psychedelics’

The Guardian - US

The Future of Psychedelic Research Is In Limbo — Why the FDA’s Decision Changed Everything

The FDA just rejected MDMA-assisted therapy for PTSD. What's next for psychedelic drugs in science and everyday life?

Inverse

FDA rejects MDMA-assisted therapy for PTSD treatment – a drug researcher explains the challenges psychedelics face

Drugmaker Lykos Therapeutics announced on Aug. 9, 2024, that the Food and Drug Administration declined to approve the company’s application for the use of MDMA-assisted therapy in the treatment of post-traumatic stress disorder. It is the first such decision issued on a psychedelic drug application.

The Conversation

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FDA Declines To Approve MDMA-Assisted Psychotherapy As a PTSD Treatment

The FDA, which approved the protocols for the studies it now questions, is asking for an additional Phase 3 clinical trial, which would take years and millions of dollars.

Reason

FDA rejects MDMA therapy for treatment of PTSD. What’s next? - Roll Call

The Food and Drug Administration declined to approve MDMA as the first psychedelic drug used to treat post-traumatic stress disorder.

Roll Call

FDA Declines Approval For MDMA As PTSD Treatment

FDA declines approval for MDMA as PTSD treatment, citing safety and efficacy concerns. Further trials needed.

Top News

FDA won't approve psychedelic MDMA for PTSD, calling for additional study

Federal health officials have declined to approve the psychedelic drug MDMA as a therapy for PTSD

The Independent UK

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The FDA and psychedelic research

To move the drugs forward, manufacturers may need to follow the agency’s advice for elevating evidence quality

Salon

1 Biotech Stock Under $10 That Could Surge 420%

Down 84% from all-time highs, Compass Pathways is a beaten-down biotech stock that trades at a massive discount to consensus price target estimates in 2024.

Barchart

Veterans lobbied for psychedelic therapy, but it may not be enough to save MDMA drug application

Military veterans have spent years lobbying for the use of psychedelic drugs to treat PTSD, but a sharply critical review of the club drug MDMA has put the therapy's approval in doubt

The Independent UK

Buy the Dip in This Biotech After Negative FDA News, Says Analyst

MindMed is a high-flying pre-revenue company that has more than doubled investor returns in the last 12 months.

Barchart

Landmark review spotlights challenge of judging psychedelic therapies

FDA advisers this week will scrutinize what could become the first approved psychedelic drug.

Axios

As the FDA evaluates ecstasy treatment for PTSD, questions mount about the evidence

Clinical trials of MDMA have been promising, but concerns have emerged about the quality of the research. A June hearing scheduled by the Food and Drug Administration is likely to address them.

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