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Patients must be informed about how and when algorithms intervene, particularly in therapies that auto-modulate dosage or target dynamically evolving infections

The product is manufactured under USP and cGMP standards at Pfizer-operated facilities

This approval marks a major advancement in bioelectronic medicine, offering a new treatment avenue for patients who haven't responded adequately to conventional therapies

Rivfloza met the primary endpoint in PHYOXTM2 as patients in the treatment group saw a marked reduction from baseline in 24-hour-urinary oxalate (Uox) excretion from Day 90 to Day 180, according to Novos press release announcing the decision