The investigational product is an extended-release tablet formulation of diazoxide chloride, the crystalline salt of diazoxide.
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The updated label now includes 3-year data from AURORA 2, a double-blind, placebo-controlled extension study.
Cases of ICP were reported in pregnant patients receiving azathioprine or 6-mercaptopurine to treat inflammatory bowel disease or systemic lupus erythematosus.
Dr Charles Raison, the Director of Clinical Research at the Usona Institute and Professor in the Department of Psychiatry at the University of Wisconsin–Madison, talks to MPR about the potential of psilocybin as a therapy for major depressive disorder.
The conversion from accelerated to traditional approval was based on data from the phase 3 innovaTV 301 clinical trial.
The phase 3 STRIDE-10 trial evaluated the safety and immunogenicity of V116 in pneumococcal vaccine-naive adults 50 years of age and older.
Sustained spread among cows would give the virus more chances to become more transmissible among humans. Experts believe pasteurization, in which milk is briefly heated, should kill the virus.
Patients are presenting with headache, hearing or vision issues.
More than half are very likely to get vaccinated; vaccination rates higher for those who perceive RSV as serious
Findings based on review of national versus WHO guidelines