mRNA-1273 vaccine (Moderna) shows strong effectiveness in reducing symptomatic SARS-CoV-2 infection and COVID-19-related hospitalization in children aged 6 months to 5 years. Further research is needed to explore long-term effectiveness and the potential need for booster doses.
CDER chief says ‘standards have not changed,’ explaining increase in CRLs for biologics
The FDA initially rejected nearly half of all biologics applications received last year, many for quality-related CMC issues that need to be improved upon, according
August 24, 2024