FDA grants Qiagen an emergency use authorization for its QIAreach SARS CoV-2 antigen test, a rapid portable test that can process an average of around...
FDA has approved a Genzyme BLA for Nexviazyme for intravenous infusion to treat patients one year of age and older with late-onset Pompe disease.
FDA classifies as Class 1 a Boston Scientific recall of its Ingenio pacemakers and CRT-Ps due to safety mode transition error.
FDA releases a final guidance on Development and Submission of Near Infrared Analytical Procedures.
Federal Register notice: FDA announces its implementation of a court decision that ruled the agency is not afforded discretion when a combination prod...
Federal Register notice: FDA extends the period for states to decide whether to sign the final standard memorandum of understanding for compounded dru...
FDA sends Spectrum Pharmaceuticals a complete response letter on its BLA for Rolontis (eflapegrastim), citing deficiencies related to manufacturing an...
Boston Scientific begins enrolling in the HI-PEITHO clinical trial to compare its EkoSonic Endovascular System in combination with anticoagulation the...