FDA Authorizes Updated Novavax COVID-19 Vaccine Â
The FDA has granted emergency use authorization for an updated Novavax COVID-19 vaccine targeting current variants.Â
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FDA Authorizes Updated Novavax COVID-19 Vaccine Â
The FDA has granted emergency use authorization for an updated Novavax COVID-19 vaccine targeting current variants.Â
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FDA Authorizes Roche 4-in-1 Test for SARS-CoV-2, Influenza A/B, RSV
The FDA issued emergency use authorization to Roche’s cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test, the company reports.
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FDA Authorizes Pemgarda for COVID-19 Prevention
Invivyd’s Pemgarda receives FDA authorization for COVID-19 prevention in immunocompromised individuals. Explore the significance of this breakthrough therapy and its potential to safeguard vulnerable populations against the virus.
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FDA Authorizes Updated Novavax COVID-19 Vaccine
The FDA amended the emergency use authorization of the Novavax COVID-19 vaccine, adjuvanted to include the 2023-2024 formula.Â
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FDA Approves Updated COVID Vaccines from Pfizer and Moderna
The mRNA vaccines are formulated to more closely target currently circulating variants by including a monovalent component that corresponds to the Omicron variant XBB.1.5.
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FDA Approves Moderna’s Updated COVID-19 Vaccine
The FDA approved Moderna’s updated COVID-19 vaccine (Spikevax) for ages 12 years and above, and issued emergency use authorization for children age 6 months through 11 years old.
Read MoreFDA Issues EUA for COVID-19 Home Antigen Test
The over-the-counter test can be used for serial testing for people who have symptoms within the first five days of symptoms or for people who do not have symptoms.
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FDA Issues EUA for Over-the-Counter COVID-19 Antigen Test
The home test can be used for serial testing for people who have symptoms within the first six days of symptoms or for people who do not have symptoms and undergo additional testing.
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FDA Issues EUA for Injection to Treat COVID-19
The drug is approved under the EUA for the use in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.
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FDA Issues EUA for Mpox Test
Authorized to be used in professional point-of-care settings, the nucleic acid amplification test can detect mpox virus and deliver results in 25 minutes.
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FDA Green-lights BD’s Combo RSV, Flu, COVID Test
BD received FDA emergency use authorization for its new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and respiratory syncytial virus (RSV).
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FDA Authorizes Moderna, Pfizer Vaccines for Children as Young as 6 Months Old
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.Â
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FDA Expands Authorization of Pfizer COVID Booster to Kids 5-through-11
Children age 5-through-11 are now authorized to receive the Pfizer COVID booster at least five months after completion of their primary two-dose series of the Pfizer vaccine.
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FDA Authorizes First COVID-Flu-RSV Test Without a Prescription
The US FDA authorized use of the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test — the first COVID-Flu-RSV test without the need for a prescription.
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FDA Limits Use of J&J Janssen COVID-19 Vaccine
The FDA limited authorized use of the J&J Janssen COVID-19 vaccine to certain individuals due to risk of thrombosis with thrombocytopenia syndrome.
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FDA Authorizes Opti Medical COVID-19/Flu Test
The US FDA granted Emergency Use Authorization for the Opti SARS-CoV-2/Influenza A/B RT-PCR Test from OPTI Medical Systems.
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First COVID-19 Breathalyzer Test Authorized by FDA
The FDA authorized the InspectIR COVID-19 Breathalyzer — the first COVID test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection.
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FDA Delays Meeting on Pfizer Vaccine for Children 6-months to Age 5
The FDA has postponed a Feb 15 meeting of its Vaccines and Related Biological Products Advisory Committee that was intended to discuss emergency use authorization of a two-dose regimen of the Pfizer-BioNTech vaccine for children age 6-months through 4-years-old.
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FDA Authorizes New Omicron-effective Monoclonal Antibody Bebtelovimab
The FDA authorized Eli Lilly and Co’s bebtelovimab, a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant.
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Novavax Vaccine Submitted for FDA Emergency Use Authorization
Novavax Inc has submitted a request to the US FDA for Emergency Use Authorization for its COVID-19 vaccine NVX-CoV2373 for patients 18 and older.
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Siemens Healthineers CliniTest Antigen COVID Test Authorized by FDA
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.
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Moderna Booster Interval Authorized for Five Months
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.
Read MoreFDA Authorizes Pfizer Booster for Children Age 12-15
The Pfizer and BioNTech COVID-19 vaccine is the first to be FDA-authorized as a booster for adolescents 12 through 15 years of age in the US.
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FDA Authorizes Merck Molnupiravir Antiviral COVID Pill
The FDA issued emergency authorization for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults age 18 and older with positive results of direct SARS-CoV-2 viral testing.
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