The nAbCyte cell-based neutralizing antibody assay detects AAVRh74var pre-existing neutralizing antibodies, which could impact patient safety and/or efficacy with Beqvez.
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Recommendations include transvaginal ultrasound of posterior compartment, observation of relative positioning of uterus, ovaries.
The approval was supported by data from the randomized, intra-patient controlled INSITE trial.
Sixty-seven percent increase in utilization tied to a concomitant 38.1 percent decrease in positivity rate.
Combining self-sampling with phone-based patient navigation further increases screening participation.
Lower prevalence of mammogram seen for women with three or more versus no adverse social determinants of health, health-related social needs
Asthma treatment gains approval for severe cases in pediatrics; Dovato gains expanded indication; Decision taken to remove ALS drug from market; Complete Response Letter issued for apomorphine device; At-home Mpox test kit made available.
The FDA clearance was based on data from a prospective clinical study of 3456 patients.
The use of whole blood at the point of care eliminates the need for plasma extraction.
Preexposure prophylaxis approved for COVID-19; Nexletol and Nexlizet gain expanded approval; Novel Duchenne muscular dystrophy treatment; First blood test to screen for malaria in donors; Warning letter for OTC topical analgesic products.
Simple risk score, including nine covariates, predicted risk for CP-AKI in monotonic manner in derivation, validation cohorts.
Quality performance measure that tracks rates of follow-up within 6 months of abnormal SBT result is feasible, valid, reliable.
The test screens whole blood samples for the 5 main species of Plasmodium parasites.
Of those newly eligible under 2021 criteria, 2,063,840 were aged 50 to 54 years and 4,020,879 had 20 to 29-pack-year smoking history.
The approval also includes a new formulation of the drug, Edurant PED (rilpivirine), a 2.5mg tablet for oral suspension.
Prevalence of obstructive coronary artery disease, revascularization rates increased with increasing CAC score.
The decision reflects the reality that COVID-19 cases are falling as the respiratory virus season winds down.
The expanded approval was supported by data from 3 trials that evaluated the effectiveness of Definity in pediatric patients.
Findings show 14% decreased colorectal cancer mortality over 14 years.
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