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Lyumjev first received FDA approval in June 2020 to reduce blood sugar levels and accelerate insulin uptake following meals in adults with type 1 and 2 diabetes. Read More
The warning letter is among a recent spate of letters by the agency aimed at stopping the marketing of unauthorized products related to the COVID-19 pandemic. Read More
The agency noted that the products are subject to detention and refusal of admission if they are offered for importation into the United States. Read More
Qiagen’s QIAreach SARS-CoV-2 Antigen Test can provide results in two to 15 minutes by analyzing more than 30 samples per hour for the antigen of the virus that causes COVID-19. Read More