Cardiovascular risk assessment of drugs for the treatment of type 2 diabetes mellitus and related FDA guidance

CT-P10, a proposed biosimilar to Rituxan (rituximab) by Celltrion, Inc.

Recommendations on the selection of strains to be included in an influenza virus vaccine for the 2019 Southern Hemisphere influenza season

Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Updates on general safety topics.