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A Maryland federal judge dismisses a physicians bid to force FDA to create a special, conditional access pathway for certain exper...[ Price : $8.95]
FDA accepts for priority review a Savara BLA for Molbreevi as a treatment for autoimmune pulmonary alveolar proteinosis.[ Price : $8.95]
CDER acting director Tracy Beth Hoeg says the Center is preparing new safety reviews of widely used antidepressants and monoclonal...[ Price : $8.95]
Hyloris Pharmaceuticals says a recent FDA inspection of its Greek manufacturing partner resulted in an Official Action Indicated d...[ Price : $8.95]
A patient safety group urges FDA to rescind or narrow a recent device clearance that allows use of a robotic surgical system in ni...[ Price : $8.95]
FDA releases the 19-page form FDA-483 with seven observations from an inspection at the Lupin drug manufacturing facility in Verna...[ Price : $8.95]
A new JAMA Health Forum analysis examines FDAs shift in how it seeks outside scientific advice while shunning advisory committee m...[ Price : $8.95]
FDA grants Pilatus Biosciences a fast-track designation for its lead drug candidate, PLT012, for treating hepatocellular carcinoma...