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FDA Places Restrictions for Obeticholic Acid (Ocaliva)

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

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...
COVID-19 Vaccine of CanSinoBIO Receives European GMP

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

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...