FDA clears an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negative systemic inflamm...
Two stakeholders make suggestions for changes to an FDA draft guidance on investigator responsibility for safety reporting for investigational drugs a...
FDAs Antimicrobial Drugs Advisory Committee narrowly votes 13-10 to recommend an emergency use authorization for Mercks oral antiviral molnupiravir fo...
FDA issues a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the companys Covid-19 vaccine candidate, BBV152, which is kno...
Stakeholders express concerns about an FDA decision in response to an appeals court ruling to reclassify some drugs as drug-led combination products.
FDA warns Invacare about QS violations found in inspections at three of its oxygen concentrator manufacturing facilities.
Teleflex recalls its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device Kit, 7FR, after receiving reports about the inner lumen becoming d...
FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mut...