Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and its use in treating H...
FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provides current agency sp...
Federal Register notice: FDA revokes a 2020 emergency use authorization granted to Roche Molecular Systems for the cobas SARS-CoV2 & Influenza A/B nuc...
Federal Register notice: FDA classifies intervertebral body graft containment devices into Class 2 (special controls).
FDA warns Atlanta, GA-based physician Julio Flamini about concerns related to investigations at his Clinical Integrative Research Center of Atlanta.
FDA warns Coral Gables, FL-based Mother Stem Institute about illegally marketing stromal vascular fraction products derived from donor adipose tissue ...
PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.
Ali Pharmaceutical asks FDA to require AbbVie to stop saying it is using Alis Armour Thyroid in a clinical trial since it is using a biologic with a d...
