Blacksmith Medicines received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for FG‑2101, an LpxC inhibitor targeting Gram‑negative pathogens, securing potential priority review and extended market exclusivity. The designations accelerate clinical development pathways for a class aimed at a critical unmet need. The regulatory boost comes as WHO surveillance found roughly one in six common bacterial infections were resistant to standard treatments in 2023. The contrast—new antibiotic candidates advancing while global resistance rises—highlights urgency for novel therapies and faster development and access pathways.