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.
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.
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.
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 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.
Read MoreA 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.
Read MoreThe 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.
Read MoreThe 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.
Read MoreThe 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.
Read MoreModerna 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.
Read MoreThe 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.
Read MoreThe 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.
Read MoreThe 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.
Read MoreThe BDR-19 critical care ventilator has received emergency use authorization from the US FDA, according to Nectar Product Development and BreathDirect.
Read MoreOn 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.
Read MoreThe 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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