[ Price : $8.95]
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include ...[ Price : $8.95]
Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are erod...[ Price : $8.95]
FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomeruloscleros...[ Price : $8.95]
FDA says Novo Nordisk and Lilly should remove statements about the potential for suicidal ideation and behavior from labeling for ...[ Price : $8.95]
FDA classifies as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affe...[ Price : $8.95]
CBER says it expects to publish 35 draft and final guidances this calendar year, including several likely-to-be controversial draf...[ Price : $8.95]
FDA articulates a flexible regulatory approach to chemistry, manufacturing and controls for cell and gene therapies, a move the ag...[ Price : $8.95]
FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic ca...