BioCentury
ARTICLE | Regulation

Prasad’s hiring as head of CBER rattles biotech investors

XBI falls as investors, biotech CEOs weigh whether approval bar will rise

May 7, 2025 1:20 AM UTC
Updated on May 7, 2025 at 7:18 PM UTC

FDA’s announcement that Vinay Prasad would succeed Peter Marks as director of CBER sent the closely watched XBI biotech ETF sharply lower on Tuesday as investors digested what hiring a fierce critic of some past FDA decisions to a top agency post would mean for industry. 

Prasad’s prior criticism of FDA policy may have investors expecting a higher bar for approvals, or a return historical standards for certain indications and technologies. ...