The Agency reviewed case reports from the FAERS database and calls from US poison control centers related to systemic symptoms after applying alcohol-based hand sanitizers to the skin.
The new 200mg single-dose prefilled pen features a hidden needle and single-press auto-injection, along with visual and audio feedback to help with administration.
The pivotal phase 3 PREVENT-19 trial evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 in 29,960 participants 18 years of age and older in the US and Mexico.
The submission is based on data from the phase 2/3 TeenCOVE study, which included over 3700 US adolescents aged 12 to less than 18 years.
The approval was based on data from a phase 3 study that evaluated Trikafta in 66 children 6 to 11 years of age with CF who were either homozygous for the F508del mutation or heterozygous for the F508del mutation and 1 minimal function mutation.
REGEN-COV (casirivimab and imdevimab) is a cocktail of 2 monoclonal antibodies.
Results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests should not be interpreted as an indication of a specific level of immunity or protection from SARS-CoV-2 infection.
Previously, the initial loading dose of Nuzyra for CABP was administered only by IV infusion.
The EUA was granted based on an interim analysis from the phase 1/2/3 COMET-ICE trial, which evaluated sotrovimab in 583 non-hospitalized adults with mild to moderate COVID-19 at high risk of progression to severe disease.
The FDA has approved Lumakras (sotorasib) for KRAS G12C-mutated locally advanced or metastatic NSCLC after at least 1 prior systemic therapy.
