Vinay Prasad's abrupt departure as Director of the FDA’s Center for Biologics Evaluation and Research (CBER) has sent shockwaves through the biotech sector. Prasad's tenure, though brief, was marked by contentious regulatory decisions including a temporary hold on Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy, Elevidys. The FDA later reversed the hold for ambulatory patients amidst investigations into patient deaths possibly linked to the therapy. This leadership change, accompanied by political pressures and backlash from various stakeholders, poses uncertainty for the FDA's biologics regulation direction.