This week we have news of the neutralizing response of the Pfizer-BioNTech vaccine to the new COVID-19 variant; A trial investigated ravulizumab in adults with severe COVID is halted; A rapid blood test for concussions gets the all clear; A novel treatment for chronic kidney disease in patients with type 2 diabetes; And the drug manufacturer Fresenius Kabi announces a voluntary recall of one lot of an NSAID treatment.
The test measures glial fibrillary acidic protein and ubiquitin carboxyl-terminal hydrolase L1, biomarkers present in blood plasma at elevated concentrations after a brain injury.
While DAAs have improved the treatment of chronic HCV infection by eliciting higher rates of sustained virologic response, they also interact with a number of agents that could potentially limit their effectiveness.
The submissions are supported by data from a phase 3 study that evaluated mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Diagnosing a disease can be challenging, especially when symptoms are common or non-specific.
The sBLA approval was based on data from a phase 3 study evaluating Xeomin in 216 patients aged 6 to 17 years with chronic sialorrhea associated with cerebral palsy, other genetic or congenital disorders, or traumatic brain injury.
The Infectious Diseases Society of America, American Academy of Neurology, and American College of Rheumatology provided new clinical practice guidelines for Lyme disease prevention, diagnosis, and treatment.
The approval was based on data from the phase 3b ENSEMBLE PLUS study that compared the frequency and severity of infusion-related reactions for a 2-hour Ocrevus infusion time to the previously approved 3.5-hour infusion time in patients with relapsing-remitting MS.
The patient, a 67-year-old female, presented to the emergency department with altered mental status.
