CDER Director Cavazzoni has her description of CMS’ mandate corrected, the FDA approves AstraZeneca/Sanofi's nirsevimab but requires safety studies on RSV variants, Genentech and Blueprint Medicines withdraw Gavreto's medullary thyroid cancer claim due to confirmatory trial feasibility issues, and Bernie Sanders goes bold on biosimilars. 

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.

Impressive overall survival data from the Phase III ADAURA trial should boost both EGFR testing in non-small cell lung cancer, and sales of the blockbuster NSCLC therapy.

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.