FDA warns Gelderland, Netherlands-based Future Diagnostics Solutions about Quality System and Medical Device Reporting violations in its manufacturing...
The Federal Trade Commission says it is expanding its challenges to junk drug patents with warnings to 10 companies about over 300 patent listings for...
FDA issues a safety alert on the rare risk of intrahepatic cholestasis of pregnancy associated with the use of thiopurines (azathioprine, 6-mercaptopu...
The CDER Office of New Drugs says it participated in 55 novel drug approvals in 2023.
FDA gives Pfizer traditional approval for its previously accelerated-approved Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical can...
SonarMed recalls its SonarMed Airway acoustic ventilator sensors due to a restricted inner diameter of the device resulting in difficulty passing a su...
Federal Register notice: FDA schedules a 5/24 Advisory Committee meeting to discuss Novo Nordisks BLA for insulin icodec.
FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.
