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Novartis AG submits application to FDA for meningitis B vaccine candidate Bexsero


Tuesday, 17 Jun 2014 08:00am EDT 

Novartis AG:Submission of Biologic License Application (BLA) to U.S. Food and Drug Administration (FDA) for marketing approval for use of Bexsero (Multicomponent Meningococcal Group B Vaccine [recombinant, adsorbed]).Says to help protect against invasive meningococcal disease caused by serogroup B (meningitis B) in adolescents and young adults from 10 years through 25 years of age.This submission initiates rolling submission process for Bexsero to the FDA, following the receipt of Breakthrough Therapy designation in April.