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FDA issues Janssen a complete response letter on its NDA for a fixed-dose combination of canagliflozin and immediate-release metfo...[ Price : $8.95]
Cadence Pharmaceuticals petitions FDA asking it not to approve any generic or 505(b)(2) NDAs for an acetaminophen solution for int...[ Price : $8.95]
A new government report examines how observational studies contribute to the results and conclusions in comparative effectiveness ...[ Price : $8.95]
FDA approves an eNeura Therapeutics de novo petition to allow marketing of its Cerena Transcranial Magnetic Stimulator, the first ...[ Price : $8.95]
PhRMA asks FDA to include greater detail on non-inferiority designs that make limited use of statistical inference testing in its ...[ Price : $8.95]
Alexion Pharmaceuticals updates a November recall notice for its Soliris Concentrated Sollution IV Infusion to include instruction...[ Price : $8.95]
Mallinckrodt says a Phase 3 efficacy trial of its investigational MNK-155 for managing moderate to severe acute pain has met its p...[ Price : $8.95]
Members of FDAs Allergenic Products Advisory Committee vote to recommend that Mercks Grastek is safe and effective for treating gr...