FDA warns Wilmington, MA-based Azurity Pharmaceuticals it is manufacturing and marketing unapproved new drugs with CGMP violations.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Idorsia Pharmaceuticals Quviviq (daridorexant h...
FDA issues two briefing documents to facilitate discussion by the Oncology Drugs Advisory Committee of the risk/benefit assessment of using immune che...
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.
