Compass Pathways reports that its investigational psilocybin therapy met the primary endpoint in a second pivotal Phase 3 trial for treatment-resistan...
An FDA Early Alert says Trividia Health has issued updated use instructions for its True Metrix blood glucose monitors to emphasize the need to seek i...
The Senate HELP Committee offers an initial 15 recommendations for reforming FDA as part of what it says will be a collaborative, bipartisan process.
Drug advertising consultant Bob Ehrlich says the recent wave of FDA enforcement letters on drug promotion activities is reshaping how pharmaceutical c...
As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to change medical device o...
PTC Therapeutics withdraws its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, following feedback f...
Sen. Tom Cotton (R-AR) urges FDA to investigate whether illegal or unregulated Chinese-sourced active pharmaceutical ingredients have entered the U.S....
FDA issues Disc Medicine a complete response letter for its experimental therapy bitopertin, indicated for treating erythropoietic protoporphyria.
