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FDA accepts for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro for adults with recurrent o...[ Price : $8.95]
FDA cites contract drug manufacturer Cerovene Inc. for repeat current good manufacturing practice deficiencies following a recent ...[ Price : $8.95]
A Friends of Cancer Research survey report documents bottlenecks in U.S. oncology clinical trial site scale-up activation and sugg...[ Price : $8.95]
FDA issues Gasco Industrial Corp. a Form 483 for significant and repeat GMP deficiencies following a 2/17-27 inspection of the com...[ Price : $8.95]
FDA classifies a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associate...[ Price : $8.95]
A BioProcess International column praises a new FDA final guidance for introducing some flexibilities into approval of cell and ge...[ Price : $8.95]
Two Argent Fox Schiff attorneys describe an FDA proposed rule that would change how some drug manufacturers register their facilit...[ Price : $8.95]
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic imm...