Federal Register notice: FDA announces a 6/4 Psychopharmacologic Drugs Advisory Committee meeting to discuss a Lykos Therapeutics NDA for midomafetami...
CBER director Peter Marks says FDA is working to achieve 90% correct decisions on gene therapy accelerated approvals.
Three Winston & Strawn attorneys say that by declining to hear an appeal, the Supreme Court has affirmed that some state law claims may be preempted b...
CDER director Patrizia Cavazzoni provides an update on the reorganization of FDAs Office of Regulatory Affairs (ORA) regarding inspection activities, ...
FDA grants Avidity Biosciences a breakthrough therapy designation for delpacibart etedesiran and its use in treating myotonic dystrophy Type 1.
FDA reminds healthcare providers and facilities about the agencys continuing safety and quality concerns with some Getinge/Maquet cardiovascular medic...
FDA says it has worked with EPA and USDA to develop a biotechnology regulatory reform program as required by a presidential Executive Order.
FDA grants in part and denies in part a 14-year-old Kaiser Permanente petition on the development, implementation, and evaluation of REMS.
