FDA warns three companies they are selling unapproved and misbranded Covid-19 antibody tests.
University of California resident surgeon Nisarg Patel calls on Congress to make FDA an independent agency to help it weather political pressure durin...
FDA approves Novartis Cosentyx (secukinumab) for treating active non-radiographic axial spondyloarthritis.
FDA announces a 9/30 virtual public meeting entitled Patient-Reported Outcomes and Medical Device Investigations: From Conception to Implementation.
FDA warns Klarity Medical Products that it is selling an unapproved medical device and also has multiple Quality System and Medical Device Reporting r...
Federal Register notice: FDA corrects a 3/9 notice that announced the withdrawal of approval of 16 ANDAs abbreviated from multiple applicants.
FDA warns four manufacturers of unapproved injectable drugs labeled as homeopathic.
FDA warns Fenwal International about CGMP deviations in manufacturing the firms blood-pack units with and without in-line leukoreduction filters, as w...