Will the US Food and Drug Administration (FDA) grant full approval to a therapeutic use of bacteriophages before the end of 2029?

The Phage Frontier

Bacteriophage therapy (phage therapy) is widely seen as a key weapon against the growing threat of antimicrobial resistance. Currently, no phage therapy product has received full FDA approval for general clinical use, though some compassionate use cases and early-phase trials are ongoing (simulated late 2025 context). The strong 'Yes' vote is driven by the urgent need for new antimicrobial tools, the demonstrated efficacy in compassionate use, and the accelerated regulatory pathways the FDA is increasingly willing to employ for life-threatening conditions. The confluence of strong Phase 3 data from a leading candidate and regulatory urgency is highly likely to result in a full approval for a specific therapeutic use before the end of 2029.