Government ❯ Health Regulation ❯ FDA

Drug Approval Process

Bioequivalence Enforcement Actions Public Health Accelerated Approval

FDA Grants Accelerated Approval to Kresladi, First Gene Therapy for Severe Pediatric LAD-1

The one-time autologous treatment won conditional clearance on biomarker gains, requiring long‑term confirmation of benefit.

Former FDA Biologics Chief Peter Marks Joins Eli Lilly to Lead Infectious Disease and Molecule Discovery