Drug Approval Process

Bioequivalence Enforcement Actions Public Health Accelerated Approval Clinical Trials

Capricor Seeks New FDA Path for Duchenne Drug After 9–3 Advisory Vote

The company will submit an amended BLA focused on upper‑limb function and the FDA has agreed to review the data, a move that could push back the Aug. 22 decision date.

10 ARTICLES

5mo ago

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

7 ARTICLES

11mo ago

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