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Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven...

FDA Authorizes Marketing of Tobacco Products that Help Reduce Exposure to and Consumption of Nicotine for Smokers Who Use Them

The U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.'s "VLN King" and "VLN Menthol King" combusted, filtered cigarettes as...

Lion TCR Receives FDA Fast Track Designation for its HBV-specific TCR T Cell Therapy for Hepatocellular Carcinoma

Lion TCR Pte Ltd  announced that it has received Fast Track Designation from United States Food and Drug Administration (U.S. FDA) for LioCyx-M004, autologous...

Merck and Ridgeback’s Molnupiravir Receives U.S. FDA Emergency Use Authorization for the Treatment of High-Risk Adults With Mild to Moderate COVID-19

Merck, known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) has granted...

MedMira Announces VYRA CoV2Flu and Additional Regulatory Opportunities

MedMira Inc. announces the expansion of its VYRA product line by launching its VYRA CoV2Flu Rapid Antigen Rapid Test (VYRA™ CoV2Flu). Based on MedMira’s...
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