FDA issues a revised draft guidance updating its recommendations for how generic drug developers should evaluate the skin irritation and sensitization...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...
A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used with biosimilar and in...
A new Harvard Law School legal commentary argues that decades of policies designed to accelerate pharmaceutical innovation may have instead encouraged...
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...
