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FDA panel rejects MDMA-based treatment for PTSD
The Hill· 3 days agoThe Food and Drug Administration (FDA) panel voted 10-1 against endorsing the safety of MDMA in treating PTSD, and 9-2 against its efficacy. The FDA is...
FDA Panel Rejects MDMA-Assisted Therapy For PTSD
Forbes· 3 days agoTherapeutics, a company formed by the Multidisciplinary Association for Psychedelic Studies (MAPS) to develop the treatment. After listening to public...
MDMA Therapy for PTSD? FDA considers first psychedelic drug
KNBN Rapid City· 15 hours agoThe Food and Drug Administration convened a panel of outside experts Tuesday to review the latest...
Geron shares surge after U.S. FDA approves blood disorder drug
KFGO· 22 hours ago(Reuters) - Shares of Geron rose almost 16% on Friday before market, a day after getting its first...
JD Supra: FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests
JD Supra· 3 days agoRule that will regulate laboratory developed tests (LDTs) as in vitro diagnostic (IVD) medical devices. FDA published a four-year enforcement discretion phaseout plan as part ...
US FDA expands GSK's RSV vaccine approval to adults aged 50 to 59
Reuters· 10 hours agoThe U.S. Food and Drug Administration approved the expanded use of GSK's respiratory syncytial virus...
FDA Platform Technology Designation Program aims to speed development of drugs, biological products...
JD Supra· 4 days agoFDA developed the new platform technology designation program draft guidance to fulfill its requirement under Section 506K(b) of the Federal Food, Drug, and Cosmetic Act ( ...
Moderna's RSV Vaccine Approved by FDA
Medscape· 5 days agoFor the first time, an mRNA vaccine has been approved for an indication other than COVID-19. The vaccine will join a couple other immunizations currently on the market for respiratory syncytial virus.
FDA Panel Votes Against MDMA As PTSD Treatment—A Potential Hitch For Drug’s Approval
Forbes· 4 days agoMDMA, a stimulant and psychedelic, is designated as a Schedule I drug with high potential for abuse...
FDA Reviewers Question Patient Selection for Alzheimer's Drug Candidate
MedPage Today· 2 days agoIn briefing documents released ahead of next Monday's meeting of the agency's advisory committee, ...