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.
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).
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.
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The FDA expanded emergency use for the Pfizer-BioNTech COVID-19 Vaccine single booster dose to teens 16 and 17 years of age.
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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.
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For children 5-11, the Pfizer-BioNTech COVID-19 vaccine is administered as a two-dose primary series, 3 weeks apart, but in a lower dose (10 μg).
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The FDA authorized single booster doses for the Moderna Inc and Janssen COVID-19 vaccines for certain adults age 18 and older, as well as the use of “mix and match” boosters of differing vaccines.
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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.
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Pfizer and BioNTech have requested emergency use authorization from the FDA to administer their COVID-19 vaccine (Comirnaty) to children ages 5 to 11 years old, according to a Pfizer tweet.
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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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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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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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