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FDA Panel Rejects MDMA-Assisted Therapy For PTSD
Forbes· 2 days agoTherapeutics, a company formed by the Multidisciplinary Association for Psychedelic Studies (MAPS) to develop the treatment. After listening to public...
FDA Panel to Consider Which COVID Strain to Target in an Updated Vaccine
MedPage Today· 4 days agoIn the briefing document, the FDA staff gave a brief history of coronavirus vaccines, noting that...
FDA Staff Proposes Narrow Approval for Lilly’s Alzheimer’s Drug
Bloomberg· 24 hours agoUS drug regulatory staffers are considering a more targeted approval for Eli Lilly & Co.’s...
FDA Advisers Overwhelmingly Oppose Approval of MDMA As a Psychotherapeutic Catalyst
Reason.com via AOL· 2 days ago"We remain committed to working with the FDA to address outstanding questions so that we may find a...
FDA approves first liquid, nonstimulant ADHD treatment
Medical Xpress· 3 days agoThe U.S. Food and Drug Administration has approved Tris Pharma's once-daily Onyda XR (clonidine...
JD Supra: FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests
JD Supra· 2 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 ...
FDA analysis raises no major concerns about Eli Lilly Alzheimer's drug
KSL Salt Lake City· 1 day agoAn FDA analysis of trial data for Eli Lilly's experimental Alzheimer's drug donanemab released on...
FDA panel rejects MDMA-based treatment for PTSD
The Hill· 2 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 advisors express skepticism as they debate MDMA therapy for PTSD
WUSF 89.7· 3 days agoTuesday, scientific advisors to the Food and Drug Administration are deciding whether to recommend...
FDA Platform Technology Designation Program aims to speed development of drugs, biological products...
JD Supra· 3 days agoFDA developed the new platform technology designation program draft guidance to fulfill its requirement under Section 506K(b) of the Federal Food, Drug, and Cosmetic Act ( ...