The U.S Food and Drug Administration (FDA) authorized the marketing of unique autism diagnostic device developed by Cognoa to help diagnose autism spectrum disorder (ASD) in young children between 18 months and 5 years of age. Using a machine learning- based software...
Israel’s Ministry of Health has found a possible link between myocarditis (heart inflammation) in males aged 16-30 and the second Pfizer vaccine. In examining the matter, the Ministry has disclosed the findings of its commissioned study stating that among the total 5...
The U.S. Food and Drug Administration (FDA) has given Amgen’s Lumakras (sotorasib) accelerated approval as a treatment for patients diagnosed with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) – the first FDA approved...
Fennec Pharmaceuticals has resubmitted their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PEDMARK™, a unique sodium thiosulfate formulation. PEDMARK is designed to prevent ototoxicity caused by cisplatin chemotherapy in patients under...
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...
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 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...
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