Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the...
Amarin Corporation PLC announced today (2/9) that its corporate partner, Edding, has progressed VASCEPA® (icosapent ethyl) for Hong Kong and Mainland China’s regulatory review processes. Based on the clinical data for VASCEPA®, including Phase III studies...
The U.S. Food and Drug Administration (FDA) has granted Puzzle Medical Devices Inc. a Breakthrough Device Designation for its minimally invasive transcatheter heart pump. The revolutionary device is meant for patients with minimal trauma for blood components to...
Janssen Biotech, a Johnson & Johnson company, submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its single dose COVID-19 vaccine. The submission is based on topline safety and efficacy data from the Phase...
Singapore has become the first Asian country that has approved the Moderna COVID-19 vaccine as it begins its efforts in implementing its immunization program. The first shipment of Moderna’s vaccine is expected sometime around March. Currently, 175,000 of Singapore’s...
The U.S. Food and Drug Administration (FDA) has outlined an interim process for drug developers to relay any problems identified during record reviews instead of, or in advance of, preapproval inspections. Their responses will be taken into consideration before action...
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