[ 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 warns Indias Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondi...[ Price : $8.95]
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug...[ 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...