Alcon announces positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512...
Federal Register notice: FDA announces the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare pediatric disease pr...
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.
