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CNP analogue

Vosoritide updates

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4 changes for Vosoritide in the last 12 months. Latest: 2026-07-29.

DateTypeWhat changedSource
2026-07-29Federal RegisterFederal Register notice: Product-Specific Guidances; Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2026-03-02TrialNew trial registered: Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With AchondroplasiaTrial register ClinicalTrials.gov
2025-12-05Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2025-11-25LabelFDA label revised: VOXZOGO 0.4mg (NDA214938)Regulator FDA drug label register
2025-08-17TrialNew trial registered: A Study of Vosoritide Versus Placebo in Children With Hypochondroplasia Aged 0 to < 36 MonthsTrial register ClinicalTrials.gov
2025-07-18TrialNew trial registered: Long-Term Extension Study of Vosoritide to Treat Children With HypochondroplasiaTrial register ClinicalTrials.gov
2024-10-31TrialNew trial registered: A Study of Vosoritide in Children With Noonan Syndrome With Inadequate Growth During or After Human Growth Hormone TreatmentTrial register ClinicalTrials.gov
2024-06-13ResultsResults posted: A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With AchondroplasiaTrial register ClinicalTrials.gov
2024-06-12TrialNew trial registered: Interventional Study of Vosoritide for the Treatment of Children With HypochondroplasiaTrial register ClinicalTrials.gov
2024-04-24TrialNew trial registered: A Phase 2 Study of Vosoritide in Children With Idiopathic Short StatureTrial register ClinicalTrials.gov
2024-03-04Federal RegisterFederal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; VOXZOGORegulator Federal Register
2023-05-08TrialNew trial registered: Vosoritide for Short Stature in Turner SyndromeTrial register ClinicalTrials.gov
2023-05-06TrialNew trial registered: Safety and Efficacy of Voxzogo for Growth Deficits in MPS IVA and VITrial register ClinicalTrials.gov
2023-02-17Federal RegisterFederal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; AvailabilityRegulator Federal Register
2022-09-06Federal RegisterFederal Register notice: Issuance of Priority Review Voucher; Rare Pediatric Disease ProductRegulator Federal Register
2022-03-02ResultsResults posted: A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With AchondroplasiaTrial register ClinicalTrials.gov
2021-01-15ResultsResults posted: A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With AchondroplasiaTrial register ClinicalTrials.gov
2020-09-18TrialNew trial registered: A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With AchondroplasiaTrial register ClinicalTrials.gov
2020-01-06TrialNew trial registered: Vosoritide for Selected Genetic Causes of Short StatureTrial register ClinicalTrials.gov
2019-05-22TrialNew trial registered: An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With AchondroplasiaTrial register ClinicalTrials.gov
2018-06-14TrialNew trial registered: A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With AchondroplasiaTrial register ClinicalTrials.gov
2017-12-28TrialNew trial registered: An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With AchondroplasiaTrial register ClinicalTrials.gov
2017-05-23TrialNew trial registered: A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With AchondroplasiaTrial register ClinicalTrials.gov
2016-02-12TrialNew trial registered: A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH)Trial register ClinicalTrials.gov
2013-04-18TrialNew trial registered: A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With AchondroplasiaTrial register ClinicalTrials.gov
2012-03-14TrialNew trial registered: A Study to Evaluate Safety and Tolerability of BMN 111 Administered to Healthy Adult VolunteersTrial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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