Hyloris Pharmaceuticals says a recent FDA inspection of its Greek manufacturing partner resulted in an Official Action Indicated designation that coul...
A patient safety group urges FDA to rescind or narrow a recent device clearance that allows use of a robotic surgical system in nipple-sparing mastect...
FDA releases the 19-page form FDA-483 with seven observations from an inspection at the Lupin drug manufacturing facility in Verna, Salcette, Goa, Ind...
A new JAMA Health Forum analysis examines FDAs shift in how it seeks outside scientific advice while shunning advisory committee meetings, raising leg...
FDA grants Pilatus Biosciences a fast-track designation for its lead drug candidate, PLT012, for treating hepatocellular carcinoma.
Minutes from a 1/21 GDUFA 4 reauthorization negotiating session show back and forth between FDA and industry participants on several topics.
FDA warns Dr. Bertrand Cole in Portsmouth, NH, about failing to conduct a clinical study according to the investigational plan.
FDA reverses course and agrees to review Modernas seasonal influenza mRNA vaccine after previously refusing to file the BLA.
