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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...
FDA panel to evaluate psychedelic MDMA for treatment of PTSD for first time
Fox News· 24 hours agoA panel of advisers to the U.S. Food and Drug Administration will meet to discuss a therapy based on...
FDA panel rejects MDMA therapy for treating patients with PTSD
WSB Radio· 14 hours agoAn independent advisory panel of the Food and Drug Administration on Tuesday rejected the use of...
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JD Supra· 1 day agoFDA developed the new platform technology designation program draft guidance to fulfill its requirement under Section 506K(b) of the Federal Food, Drug, and Cosmetic Act ( ...
High Confidence AD Drug Donanemab Will Get FDA Panel Nod
Medscape· 1 day agoThe Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug...
FDA panel to review psychedelic drug MDMA for first time
KSL Salt Lake City· 1 day agoThe meeting by the agency's independent experts is the farthest that a drug based on MDMA, commonly...
FDA advisers consider MDMA therapy to treat PTSD - WSVN 7News | Miami News, Weather, Sports | Fort...
7 News Miami· 1 day agoIt’s the first time the FDA’s advisers have considered a psychedelic drug for medical use. The novel...
Denali, Neurogene and more picked by FDA's 'Operation Warp Speed' for rare disease
FierceBiotech· 19 hours agoThe FDA’s “Operation Warp Speed” equivalent for rare disease will include programs from Denali...
Whooping cough map reveals why FDA is concerned
Newsweek· 4 hours agoWhooping cough cases in the U.S. have surged this year, and the U.S. Food and Drug Administration (FDA) is concerned. The illness, also known as pertussis, has seen a drastic ...
FDA Panel Votes Against MDMA As PTSD Treatment—A Potential Hitch For Drug’s Approval
Forbes· 1 day agoThe FDA will make a final decision on the proposal on Aug. 11 and does not have to follow the...
