FDA accepts for priority review a Savara BLA for Molbreevi as a treatment for autoimmune pulmonary alveolar proteinosis.
CDER acting director Tracy Beth Hoeg says the Center is preparing new safety reviews of widely used antidepressants and monoclonal antibodies for resp...
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.
