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FDA publishes a draft guidance on incorporating QTc prolongation-related information in drug and biological product labeling.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Morgan Lewis attorneys say a recent FDA draft guidance further demonstrates the agencys interest in modernizing good clinical practice guidelines to r...
Federal Register notice: FDA seeks comments on an information collection extension entitled Good Laboratory Practice Requirements for Nonclinical Labo...
