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...
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...
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