The US FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend emergency use authorization for a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level.
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.
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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The Ellume COVID-19 Home Test is the first over-the-counter fully at-home diagnostic test for COVID-19. Ellume is a rapid, lateral flow antigen test.
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The US FDA issued a new emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card Home Test, which is now authorized for use by patients at home with a prescription.
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The US FDA issued emergency use authorization late Friday to Pfizer and BioNTech’s COVID-19 vaccine, and 2.9 million doses of the vaccine were shipped to 636 sites across the country.
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The US FDA has issued the first emergency use authorization for a vaccine for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
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The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for home collection of patient samples to detect both COVID-19 and influenza A and B (flu).
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The US FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Dec 17 to discuss emergency authorization for Moderna’s COVID-19 vaccine candidate.
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An FDA vaccine advisory panel will meet on Dec 10 to discuss an emergency authorization of Pfizer’s COVID-19 vaccine candidate BNT162b2.
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The FDA issued an EUA for the drug baricitinib in combination with remdesivir to treat patients age two and older who are hospitalized COVID-19.
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The FDA has authorized the Lucira COVID-19 All-In-One Test Kit — the first coronavirus diagnostic for self-testing at home and that provides rapid results.
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The monoclonal antibody bamlanivimab reduced COVID-19-related hospitalization or ER visits in patients at high risk for disease progression within 28 days after treatment.
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Remdesivir (trade name Veklury) is now authorized to treat all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
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