FDA says the Baxter 2/5 recall of specific Spectrum infusion pumps was Class 1.
FDA publishes the FY 2025 OTC monograph drug facility fee and contract manufacturing organization fees.
FDA sends Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar disc herniation.
FDA delays its decision on an IceCure Medical de novo marketing authorization request for the ProSense cryoblation device and its use in early-stage l...
FDA awards PEP-Therapy an orphan drug designation for PEP-010 and its used for treating pancreatic cancer.
Becton, Dickinson corrects software for the BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter after receiving reports that cu...
Federal Register notice: FDA revokes Emergency Use Authorizations issued to Beckman Coulter for three of its Access branded Covid-19 tests.
FDA warns South Africas Aspen Pharmacare about CGMP violations in its production of finished drugs as a contract manufacturing facility.
