Novartis's Bexsero Receives FDA Breakthrough Therapy Designation
Novartis receives FDA breakthrough therapy designation for Bexsero, a meningitis B vaccine.
Novartis
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.
Source:
Novartis
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
