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.
Tag: FDA emergency use authorization
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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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AstraZeneca Long-Acting Monoclonal Antibodies Authorized
The FDA has issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab and cilgavimab) to prevent COVID-19 in certain adults and children.
AstraZeneca Requests Emergency Use for COVID-19 Antibody
AstraZeneca has submitted a request to the FDA for an emergency use authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.
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Pfizer Booster Dose Authorized for Americans 65+ and Those at High Risk of Severe COVID-19
A single booster dose of the Pfizer-BioNTech COVID-19 vaccine was authorized by the FDA for Americans 65+ and others 18 and older at high risk of severe COVID-19, including those with risk of occupational exposure.
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FDA Vaccine Committee Unanimously Favors Vaccine Boosters in Americans 65+
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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FDA Authorizes Monoclonal Antibody Actemra for Hospitalized COVID-19 Patients
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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Additional Authorization for Opti Medical SARS-CoV-2 Test
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 Vaccine Submitted to FDA for EUA in Kids 12 to 17
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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Pfizer Vaccine Authorized for Adolescents Ages 12-15
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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FDA Revokes EUA for Monoclonal Antibody Bamlanivimab
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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FDA Authorizes Symbiotica COVID-19 Self-Collected Antibody Test
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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BreathDirect Ventilator Authorized by FDA
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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FDA Authorizes J&J COVID-19 Vaccine
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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FDA Authorizes Monoclonal Antibodies for COVID-19
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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