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FDA Panel Rejects MDMA Treatment
newser· 10 hours agoHistoric: FDA advisers have never before considered a Schedule I psychedelic drug for medical use. In addition, no new treatment for PTSD has been ...
Psychedelic-medicine stocks drop after ecstasy’s rocky day at the FDA
Market Watch· 3 hours agoPrivately held Lykos Therapeutics is seeking FDA approval for the treatment combining talk therapy...
FDA Panel Rejects MDMA Therapy For PTSD, Citing Concerns Over Research Data In Setback For Advocates
Benzinga· 13 hours agoA committee of advisors to the U.S. Food and Drug Administration (FDA) dealt a blow to the...
FDA panel rejects first MDMA treatment amid deep concerns about flawed trials
NBC NEWS· 18 hours agoIf approved by the FDA, it would be the first new treatment for PTSD in more than two decades. The...
FDA Panel Rejects MDMA Drug for PTSD
Medscape· 10 hours agoA US Food and Drug Administration (FDA) expert panel has found that the benefits of the psychedelic midomafetamine (MDMA) in combination with psychological intervention for ...
FDA panel rejects first MDMA treatment amid deep concerns about flawed trials
AOL· 17 hours agoThe two votes — one for the treatment’s efficacy and one for its safety, by the agency’s Psychopharmacologic Drugs Advisory Committee — marked the first time that FDA advisers ...
The FDA may approve psychedelics for treating PTSD. Here's what to know
Quartz· 2 days agoThe public benefit company Lykos Therapeutics submitted a new drug application late last year to the...
FDA Approves Nonstimulant Liquid Onyda XR for ADHD
Medscape· 6 days agoThe centrally acting alpha2-adrenergic agonist allows for nighttime dosing and can be used with stimulants, the drug's manufacturer says.
FDA Platform Technology Designation Program aims to speed development of drugs, biological products...
JD Supra· 1 day agoFDA developed the new platform technology designation program draft guidance to fulfill its requirement under Section 506K(b) of the Federal Food, Drug, and Cosmetic Act ( ...
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
Zacks via Yahoo Finance· 5 days agoPer the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication...
