[ Price : $8.95]
FDA grants Novartis a breakthrough therapy designation for LEE011 (ribociclib) and its use in combination with letrozole for treat...[ Price : $8.95]
Par Sterile Products asks FDA not to approve any generic form of its Adrenalin that does not contain the same inactive ingredients...[ Price : $8.95]
Former FDA Webview consulting editor and longtime FDA stalwart John H. Scharmann dies at the age of 84, after a lengthy, valiant b...[ Price : $8.95]
Four stakeholders recommend changes to a draft biosimilar labeling guidance to include clinical data.[ Price : $8.95]
Bayer wins a court victory in a product liability case that cited an FDA-483 about its besieged Essure contraceptive device.[ Price : $8.95]
FDA warns Chinas Xiamen Origin Biotech about CGMP violations in manufacturing APIs.[ Price : $8.95]
FDAs Los Angeles District Office warns TriMed about Quality System violations in its manufacturing of implantable bone fixation sy...[ Price : $8.95]
FDA publishes a draft guidance to harmonize agency and IEC performance standards for medical x-ray imaging equipment.