mRNA-1010

The FDA has ordered Pfizer and Moderna to expand warning labels on their COVID-19 vaccines regarding myocarditis and pericarditis risk, particularly in males aged 16-25, with an incidence rate of 38 cases per million doses.

Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.

Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.

The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022.

Basilea Pharmaceutica's Zevtera (ceftobiprole) receives FDA approval for three indications, becoming the first beta-lactam antibiotic approved for Staphylococcus aureus bacteremia.