FDA Expands Use of Bioelectronic Device ClearUp to Include Sinus Congestion
The bioelectronic device was previously approved for treating sinus pain due to allergic rhinitis.
The bioelectronic device was previously approved for treating sinus pain due to allergic rhinitis.
Bronchitol should only be used by adults who have passed the Bronchitol Tolerance Test.
The phase 2/3 KidCOVE study [ClinicalTrials.gov: NCT04796896] is evaluating the safety and effectiveness of the vaccine in healthy children between 6 months and less than 12 years of age.
Lorbrena is a third generation ALK tyrosine kinase inhibitor.
Fully vaccinated individuals can visit with other fully vaccinated people, or unvaccinated people from a single household who are at low risk for severe COVID-19 disease, indoors without wearing masks or physical distancing.
The median time to resolution of COVID-19 symptoms was 10 days with ivermectin and 12 days with placebo.
The submission was based on data from the double-blind, placebo-controlled VOYAGE trial.
The EUA was based on data from the randomized, double-blind, placebo-controlled ENSEMBLE trial.
In a safety communication, the Agency urged health care providers to only use the FDA-approved product.
In the US, a phase 1 study will evaluate mRNA-1273.351, an emerging variant booster candidate against the B.1.351 variant.