[ Price : $8.95]
FDA extends by three months its review of an Organon supplemental NDA for Vtama (tapinarof) cream and its use for treating atopic ...[ Price : $8.95]
FDA issues an untitled letter to Chinas Shandong Boyuan Pharmaceutical Co. about CGMP deviations in its manufacturing of active ph...[ Price : $8.95]
FDA warns Grand Prairie, TX-based Analytical Food Laboratories about CGMP violations in its work as a drug contract testing labora...[ Price : $8.95]
FDA clears a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons through artificial intelligence-based image ...[ Price : $8.95]
FDA extends by three months its priority review of a Merus BLA for Zeno (zenocutuzumab) for treating patients with certain types o...[ Price : $8.95]
Four rare disease stakeholders say they support an FDA plan to create a Rare Disease Innovation Hub and suggest its initial priori...[ Price : $8.95]
Attorney Bradley Thompson says he is surprised and disappointed that FDA is not approving enough new consensus standards to suppor...[ Price : $8.95]
FDA announces a pilot program designed to expedite the review of new therapies addressing unmet medical needs.