The approval was based on data from the Td537 study which included individuals 18-64 years old who had received a dose of Adacel 8-12 years prior (N=1330).
According to the Company, a Phase 1 placebo-controlled, dose-escalation study of BXCL501 is expected to enroll up to 60 healthy adults across various dosing groups; pharmacokinetics and safety will be evaluated as primary endpoints.
Reports of serious adverse events related to dietary supplements containing the unapproved opioid-like antidepressant tianeptine have prompted FDA warnings.
Pimodivir was found to be beneficial in the treatment of acute uncomplicated influenza A virus infection in adult patients.
The FDA has approved the use of Oralair for the treatment of grass pollen-induced allergic rhinitis in pediatric patients aged 5-9.
The FDA has issued a safety communication alerting patients and healthcare providers that for some EpiPen and EpiPen Jr auto-injectors, and their authorized generics, the device label may become stuck to the inside of the carrier tube and potentially delay administration.
To investigate the association between this commonly used antihypertensive class and lung cancer, researchers conducted a population based cohort study involving 992,061 patients from the United Kingdom Clinical Practice Research Datalink.
To better understand the influence of prior-season vaccination on subsequent influenza vaccine effectiveness, researchers conducted a multiseason, test-negative case-control study among vaccinated children 2-17 years old recruited during 3 influenza seasons (2013-2014, 2014-2015, and 2015-2016).
The FDA has approved the use of Afluria and Afluria Quadrivalent for use in patients ≥6 months old.