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The US FDA New Drug Approvals in January 2026 Shots: Approval numbers were lower, but the impact remained strong the FDA cleared one new drug in January 2026 versus three in January 2025, reflecting continued innovation in areas of high unmet need Zycubo from Sentynl Therapeutics was approved for pediatric Menkes disease, offering a targeted treatment for this rare, life-threatening genetic copper deficiency disorder Clinical results were striking, showing about an 80% reduction in risk of death and a major survival gain of 177.1 months versus 17.6 months in untreated patients, with Zycubo providing daily subcutaneous bioavailable copper replacement Company: Sentynl Therapeutics Product: Zycubo Active Ingredient: Copper Histidinate Disease: Pediatric Menkes Disease Date: Jan 12, 2026 Shots: The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos

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