Ideaya Biosciences says it is advancing darovasertib into a Phase 3 trial following positive interim Phase 2 clinical trial data on the therapys use f...
Federal Register notice: FDA withdraws approval of four NDAs from multiple sponsors because they repeatedly failed to file required annual reports.
FDA Webview editor Jim Dickinson analyzes the evolving legacy of departing CDRH director Jeff Shuren and his hand-picked interim successor Michelle Ta...
Federal Register notice: FDA makes available three draft guidances for its Accreditation Scheme for Conformity Assessment Program.
Federal Register notice: FDA makes available a draft guidance entitled Chemical Analysis for Biocompatibility Assessment of Medical Devices.
FDA approves UCBs Bimzelx (bimekizumab-bkzx) for treating adults with active psoriatic arthritis, active non-radiographic axial spondyloarthritis with...
FDA approves Zevra Therapeutics Miplyffa (arimoclomol) for treating Niemann-Pick disease, Type C (NPC) in adults and children aged two and older.
Federal Register notice: FDA announces year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot program.
