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.

Galderma said its IL-31 receptor alpha inhibitor nemolizumab succeeded in two Phase III atopic dermatitis trials, advancing the firm’s long-term goal of moving past topical dermatology drugs.

Lilly's Mounjaro and Roche's Vabysmo appear on track to be fast blockbusters in a year that saw the fewest drug launches since 2016.

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.