Peace Engine Kyoto was granted U.S. cGMP (Current Good Manufacturing Practices) by a third-party certification for its manufacturing facility in Kyoto, Japan. Previously awarded a permit in 2020 by Japan’s Ministry of Health, Labour, and Welfare for...
CanSinoBIO announced today that the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) has granted Good Manufacturing Practices (GMP) certification for its COVID-19 vaccine, Convidecia™. Dr. Xuefeng YU, Chairman and Chief Executive Officer of CanSinoBIO,...
The U.S. Food and Drug Administration (FDA) has cleared Overjet’s AI Dental Assist product, marking it the first AI technology to enter the dental industry to aid dental hygienists and dentists in real time. The SaMD (Software as a Medical Device) will support...
Since the COVID-19 outbreak in 2020, there has been a significant rise in cases of mental health issues like stress, depression, and anxiety around the world. In addition to the anxiety surrounding the virus, disruptions in daily lifestyles globally have brought...
The U.S. Food and Drug Administration (FDA) is encouraging sponsors involved in gene therapy trials to fill data gaps with remote visits and telemedicine. The encouragement comes from Wilson Bryan, the FDA’s OTAT (Office of Tissues and Advanced Therapies) during the...
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Roche for its cobas® SARS-CoV-2 Test. The cobas® SARS-CoV-2 Test is designed to test asymptomatic individuals suspected to have COVID-19. The Center for Disease Control (CDC)...
The U.S. Food and Drug Administration (FDA) authorized ImmunityBio Phase I clinical study for patients with metastatic or locally advanced solid tumors. The study will assess the safety and efficacy of ImmunityBio’s IL-15 superagonist Anktiva (N-803) in...
BD (Becton, Dickinson, and Company) announced today the first self-collection, at-home HPV screening has been CE marked to the IVD directive 98/79/EC. With this new claim, diagnostic labs will now be able to process the self-collected vaginal samples using the BD...
The U.S. Food and Drug Administration (FDA) has granted ZOLL Medical investigational device exemption (IDE) for a randomized study to evaluate TherOx® SuperSaturated Oxygen (SSO2) Therapy in patients with cardiogenic shock and ST Elevation Myocardial Infarction...
Eyepic Eye Care announced a revolutionary service using the only FDA-approved MiSight multifocal contact lenses meant to slow myopia progression in children. Myopia, which is a refractive eye condition causing nearsightedness, affects approximately 40% of Americans...
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