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FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.
FDA approves an X4 Pharmaceuticals NDA for Xolremdi (mavorixafor) and its use in patients 12 years of age and older with WHIM syndrome (warts, hypogam...
Federal Register notice: FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Correspondin...
