The FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 for in children as young as 6 months old.
The Siemens Healthineers CliniTest Rapid COVID Antigen Self-test has received FDA authorization (EUA) for unsupervised self-testing by individuals age 14 and older. The test is also authorized for adult-collected pediatric samples for children ages 2-13.
The FDA expanded emergency use for both the Moderna and Pfizer-BioNTech COVID-19 vaccine boosters for all individuals 18 years of age and older.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the emergency use for a booster dose of the Pfizer/BioNTech vaccine in individuals age 65 and older and individuals at high risk of severe COVID-19.
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The US FDA issued an emergency use authorization for the monoclonal antibody Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients age 2 and older.
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The Opti SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for sample handling using the OPTI Rapid Lysis Buffer.
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Moderna Inc has requested an emergency use authorization for its COVID-19 vaccine in adolescents age 12 to 17 with the FDA. The vaccine has been authorized for adults age 18 and older since December 2020.
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The FDA has expanded its emergency use authorization for the Pfizer/BioNTech COVID-19 vaccine to children ages 12 to 15 years old. The vaccine had been authorized for individuals ages 16 and older.
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The US FDA has revoked an EUA for the monoclonal antibody bamlanivimab when administered alone, for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.
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The US FDA has issued an EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples.
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The BDR-19 critical care ventilator has received emergency use authorization from the US FDA, according to Nectar Product Development and BreathDirect.
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On Saturday, the US FDA issued an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine from Johnson & Johnson. It is the third vaccine authorized in the United States for the prevention of COVID-19 in patients 18-and-older caused by SARS-CoV-2.
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The FDA authorized Eli Lilly and Co’s bamlanivimab and etesevimab, monoclonal antibodies for the treatment of mild to moderate COVID-19.
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A number of decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times.
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According to CNN, the Moderna rollout is four times larger than Pfizer’s and doses could be administered to healthcare workers as early as today (Dec 21).
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