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Novartis receives FDA breakthrough therapy designation for Bexsero, a meningitis B vaccine.
reported that Bexsero has received a breakthrough therapy designation from FDA. Bexsero is already approved in Europe, Canada, and Australia to help protect against meningococcal disease caused by serogroup B (meningitis B).
This announcement comes after a decision from regulators in the UK, where the Joint Committee on Vaccination and Immunization recommended the inclusion of Bexsero in the country's National Immunization Program forroutine use in infants two years and up.