FDA Places Restrictions for Obeticholic Acid (Ocaliva)
The U.S. Food and Drug Administration (FDA) has placed restrictions on the use of obeticholic acid (Ocaliva of Intercept Pharmaceuticals) in patients with primary biliary cholangitis (PBC) and advanced cirrhosis due to risk for serious liver injury. The restriction...
Belgium Suspends J&J Vaccine
The Johnson & Johnson COVID-19 vaccine has been suspended in Belgium for individuals under the age of 41 after the first reported death in the European Union linked to severe side effects associated with the shot. The European Medicines Agency (EMA) is currently...
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...