FDA accepts for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro for adults with recurrent or metastatic head an...
FDA cites contract drug manufacturer Cerovene Inc. for repeat current good manufacturing practice deficiencies following a recent inspection of its Va...
A Friends of Cancer Research survey report documents bottlenecks in U.S. oncology clinical trial site scale-up activation and suggests ways to address...
FDA issues Gasco Industrial Corp. a Form 483 for significant and repeat GMP deficiencies following a 2/17-27 inspection of the company's over-the-coun...
FDA classifies a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associated with lidocaine amp...
A BioProcess International column praises a new FDA final guidance for introducing some flexibilities into approval of cell and gene therapy products ...
Two Argent Fox Schiff attorneys describe an FDA proposed rule that would change how some drug manufacturers register their facilities and list their p...
FDAs Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic immunotherapy RP1 (vuso...
