Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.

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.

Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.