BioCentury
ARTICLE | Regulation

‘Arbitrary’ FDA decision-making puts U.S. innovation at risk, says Soon-Shiong

About-face by FDA on bladder cancer application stuns Immunitybio 

May 7, 2025 1:08 AM UTC

Veteran biotech executive Patrick Soon-Shiong warns that inconsistent and arbitrary decisions by FDA could destroy innovation in the U.S. and undermine the innovation being generated by American biotech start-ups.

“A perplexing, non-sensical regulatory environment is potentially destructive to innovation in the U.S.,” founder, executive chairman and global chief scientific and medical officer of Immunitybio Inc. (NASDAQ:IBRX), told BioCentury. “Innovation comes from young biotechs in the U.S., which cannot afford arbitrary decision-making.”...