FDA leadership has generally seemed apprehensive of going too hard on companies that don’t meet clinical trial diversity goals, but some industry insiders say a stronger FDA is needed to spark real change. Delayed guidance could indicate if the agency will change course.

The ranks of B7-H3-targeting antibody-drug conjugates under development in China have seen their first dropout, although elsewhere there are two FGFR2b-directed ADCs with first-in-class potential on the horizon. Meanwhile, there have been other discontinuations of KRAS G12C inhibitors and anti-BCMA CAR-T cell therapies in the country, while new players have surfaced in the areas of mRNA cancer vaccines and amyloid-beta-targeting antibodies for Alzheimer’s disease.

The shockwave of WuXi's withdrawal from BIO is ripping through the Chinese contract services sector. While some remain hopeful, others are preparing Plan B.

US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.