After the presentation of stellar long-term survival data at ESMO for Kisqali in women with HR+/HER2- advanced breast cancer, Novartis is planning to knock Pfizer's Ibrance off its CDK4/6 inhibitor perch with the help of a head-to-head trial.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

Adding oleclumab and monalizumab to the PD-L1 inhibitor improved PFS, while another study showed improved real-world outcomes.