Federal Register notice: FDA announces the issuance of a priority review voucher to Amryt Pharmaceuticals for its qualified rare pediatric disease pro...
FDA grants Sellas Life Sciences a fast track designation for SLS009, a highly selective CDK9 inhibitor for treating relapsed/refractory acute myeloid ...
FDA launches a new search function on its Office of Pharmaceutical Quality Web page to improve access to drug quality resources.
FDA says it cant approve Astellas zolbetuximab BLA by the 1/12 PDUFA action date due to unresolved issues at a third-party manufacturing company for t...
CBER director Peter Marks says there is a positive risk/benefit assessment for CAR-T therapy for its approved uses.
CDER director Patrizia Cavazzoni says ORP director Elizabeth Jungman will become FDA commissioner Robert Califfs chief of staff.
FDA cautions that there is the potential for elevated levels of formaldehyde being released when two GE HealthCare compressors are used with specified...
FDA warns Czechias Deymed Diagnostic about QS violations in its production of non-sterile Class 2 medical devices.
