FDA posts a draft guidance entitled Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and ...
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FDA posts a draft guidance entitled Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products.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...
CBER director Peter Marks outlines the top priorities at the Center this year that include updating the Centers tissue guidance to reduce the risk of ...
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Laboratory Values.
Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Performance Status.
