A 2023 inspection at South Koreas C&T Dream Co. leads to a nine-observation FDA Form-483 that cites significant GMP deviations.
Gilead Sciences recalls one lot of Veklury (remdesivir) for injection 100 mg/vial, after it received a customer complaint about the presence of a glas...
FDA has appointed industry veteran and consultant Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing William Maisel who r...
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 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Federal Register notice: FDA makes available a draft guidance entitled Chemical Analysis for Biocompatibility Assessment of Medical Devices.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.
