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Immunodiagnostics developer Oncimmune has inked a contract with Alphabet subsidiary Verily Life Sciences to conduct autoantibody profiling on patients who have developed long COVID-19, defined as a symptomatic case of COVID-19 that lasts for more than four weeks. Read More
The FDA should go ahead with its plans to overhaul its Quality System Regulation (QSR) to harmonize it with the International Organization for Standardization’s ISO 13485 standard, but should give device manufacturers more than one year to implement the revised regulation, industry speakers said at a meeting of the agency’s Device Good Manufacturing Practice Advisory Committee on Wednesday. Read More
To clarify the FDA’s recommendations on quickly and effectively removing potentially harmful drugs and devices from the market, the agency has published a final guidance focused on recall readiness. Read More
A clinical trial of KidneyIntelX’s Renalytix chronic kidney disease diagnostic tool showed that it can accurately forecast the rate of patients’ decline in kidney function, the company said. Read More
The FDA has extended its review period for AbbVie’s and Boehringer Ingelheim’s Skyrizi (risankizumab-rzaa) for the treatment of moderate-to-severe Crohn's disease in patients age 16 years and older, calling for details of the injector device. Read More
The Model 450 achieved a 99.99 percent kill of MS2 bacteriophage — an accepted SARS-CoV-2 surrogate — as well as a 99.99 percent kill of mold and bacterial spores, the company said. Read More