FDA issues two briefing documents to facilitate discussion by the Oncology Drugs Advisory Committee of the risk/benefit assessment of using immune che...
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...
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.
