[ Price : $8.95]
FDA revises its guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions fo...[ Price : $8.95]
Alcon announces positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy an...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare ...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of a priority review voucher to Amryt Pharmaceuticals for its qualified rare p...[ Price : $8.95]
FDA grants Sellas Life Sciences a fast track designation for SLS009, a highly selective CDK9 inhibitor for treating relapsed/refra...[ Price : $8.95]
FDA launches a new search function on its Office of Pharmaceutical Quality Web page to improve access to drug quality resources.[ Price : $8.95]
FDA says it cant approve Astellas zolbetuximab BLA by the 1/12 PDUFA action date due to unresolved issues at a third-party manufac...[ Price : $8.95]
CBER director Peter Marks says there is a positive risk/benefit assessment for CAR-T therapy for its approved uses.