SetSet’s April Pride warns the decision could results in unregulated MDMA use and calls for harm-reduction education and regulatory reforms. A Food and Drug Administration (FDA) advisory panel ...

Opinions expressed by Forbes Contributors are their own. I write about cannabis business and culture. PTSD is a serious medical condition that affects 13 million Americans any given year, or about ...

One of the Emory principal investigators, Barbara Rothbaum, MD, has also been named to a Lykos' panel that would help ensure oversight of MDMA-AT post-FDA approval. Ostacher is an investigator in ...

On Friday, drugmaker Lykos Therapeutics received word from the Food and Drug Administration that the agency has decided not to approve MDMA-assisted therapy for PTSD at this time. Instead ...

The FDA’s decision was expected after a panel of government advisors ... letters to the FDA in recent weeks urging MDMA's approval. But FDA’s review brought new scrutiny to the research.

Still, the FDA granted MDMA "breakthrough status" several years ago, essentially giving it a fast-track path through the review process. But there were unconventional elements to Lykos' work with ...

In a previous blog on the use of psychedelics to treat mental health disorders, we reported that the US Food and Drug ... of MDMA) was effective in treating PTSD, and the panel also voted 10-1 ...

The FDA’s decision comes after a key advisory panel voted that the available data does not suggest ... allowing it to move more efficiently through the development and review process. This came after ...

The U.S. Food and Drug Administration (FDA) announced Friday its rejection of MDMA as a treatment for PTSD. The decision was based on "significant limitations" that "prevent the agency from ...

The U.S. FDA followed up an unfavorable advisory committee meeting with a complete response letter (CRL) to Lykos Therapeutics Inc. for midomafetamine (MDMA) capsules, which would be used in ...

MDMA was classified as a Schedule I drug, meaning it has "no currently accepted medical use and a high potential for abuse," by the Drug Enforcement Administration in 1985. The FDA had until Aug. 11 ...