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
EMA Recommends Imfinzi-Based Perioperative Regimen for Treating Resectable NSCLC
March 10th 2025The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.
