Peace Engine Kyoto Granted cGMP Compliant by Third-Party Certification
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 manufacturing...
COVID-19 Vaccine of CanSinoBIO Receives European GMP
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,...
FDA Clears Overjet’s AI Dental Assist
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...
FDA Encourages Telemedicine For Gaps in Gene Therapy Trials
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...
FDA Authorizes Roche for Testing COVID-19 Asymptomatic Individuals
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)...
ImmunityBio Receives FDA Authorization for Clinical Study of Memory Cytokine-Enriched NK Cell (m-ceNK) Platform in Solid Tumors
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 combination...