FDA issues a revised draft guidance updating its recommendations for how generic drug developers should evaluate the skin irritation and sensitization...
FDA approves Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adu...
Sen. Ron Johnson asks to interview four former CBER officials and Anthony Fauci on the safety and efficacy of Covid vaccines.
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...
