FDA clears a Cook Medical 510(k) for the Cellvizio Confocal Laser Endomicroscopy System and the Confocal Miniprobes.
FDA Review posts the Federal Register notices for the week ending 3/16/2018.
FDA approves a Tetra Discovery Partners IND for BPN14770, a novel, selective small molecule inhibitor of the phosphodiesterase type-4D enzyme.
ederal Register notice: FDA announces a 4/23 Arthritis Advisory Committee meeting that will review an Eli Lilly NDA for baricitinib tablets.
FDA approves CSL Behrings Hizentra (immune globulin subcutaneous [human] 20% liquid) as maintenance therapy for chronic inflammatory demyelinating pol...
Federal Register notice: FDA seeks comments on an information collection extension for MedWatch: The FDA Medical Products Reporting Program (OMB Contr...
Federal Register notice: FDA amends a 1/23 notice about a 3/22 Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee ...
Q BioMed files with FDA for a new manufacturing facility to make strontium chloride Sr89 injection USP, a non-opioid injectable radiopharmaceutical to...