FDA grants HuidaGene Therapeutics a rare pediatric disease designation for HG004 and its use in treating inherited retinal disease caused by RPE65 mut...
FDA grants traditional approval for Genentechs Gavreto (pralsetinib) for treating adult patients with metastatic RET (rearranged during transfection) ...
FDA sends Galera Therapeutics a complete response letter on an NDA for avasopasem manganese for radiotherapy-induced severe oral mucositis in patients...
FDA publishes a draft guidance on incorporating QTc prolongation-related information in drug and biological product labeling.
FDA clears a Curiteva 510(k) for the Navigation Instrument System for use with its Prodigy Pedicle Screw System and SI-Lution Sacroiliac Joint Fusion ...
University researchers say a trend toward FDA approving new drugs based on less rigorous standards is continuing.
FDA and the International Pharmaceutical Regulators Programs Biosimilars Working Group announce a 9/12-13 virtual workshop on increasing the efficienc...
Morgan Lewis attorneys say a recent FDA draft guidance further demonstrates the agencys interest in modernizing good clinical practice guidelines to r...
