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.

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.

Private Company Edition: Venture capital mega-rounds of $100m or more held steady in April after a slow January and February then a surge in March, but VC fundraising is down overall this year. In recent raises, Enveda series B expanded to $119m, Vedanta brought in $106.5m and Convergent raised $90m.

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.