The FDA approved the combination therapy—previously approved for certain metastatic melanoma patients—for the treatment of metastatic non-small cell lung cancer with a BRAF V600E mutation.
The FDA expanded emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as a single booster dose for children 6 months through 4 years of age.
COVID-19 vaccines reduced the potential global death toll during the pandemic by more than half in the year following their implementation, a mathematical modeling study published in The Lancet Infectious Diseases estimates.
Pfizer and BioNTech have requested FDA authorization of a second booster dose of their COVID-19 vaccine for adults 65 years of age and older.
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A nationwide study from the U.S. Centers for Disease Control and Prevention shows that immunity against severe COVID-19 disease begins to wane four months after receipt of the third dose of an mRNA vaccine.
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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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Pfizer and BioNTech have submitted an application for emergency authorization of its COVID-19 vaccine in children age 6 months through 4 years old.
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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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The US FDA has authorized the emergency use of Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients age 12 and older.
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According to data, Pfizer’s COVID-19 antiviral Paxlovid reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) with no patient deaths.
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Vaccines conferred protection from all COVID-19 variants but there was reduced antibody neutralization of both the Beta and Delta variants.
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Experts say the success of COVID Antiviral Pills depends on whether high-risk patients will be able to get tested, and then treated, fast enough to make a difference.
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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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Pfizer says its antiviral pill Paxlovid reduced the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.
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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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