Janssen keeps Sporanox label approvals; J&J tapped as collaborator on new V-Wave heart failure trial
Two Sporanox labeling supplements remain approved this week, and Johnson & Johnson appears as a collaborator on a newly posted heart failure device trial led by V-Wave Ltd.
This week's roundup covers confirmed labeling approvals for Sporanox and a newly registered device trial naming Johnson & Johnson as a collaborator.
- Janssen Pharmaceuticals holds FDA approval for a labeling supplement covering the 100mg oral capsule formulation of Sporanox (itraconazole) under NDA020083, submission 72, with a submission status date of 2026-07-07.1
- Janssen also holds approval for a labeling supplement covering the 10mg/mL oral solution formulation of Sporanox under NDA020657, submission 45, with the same submission status date of 2026-07-07.2
- A new trial, "RELIEVE-HFrEF," was posted this week with Johnson & Johnson listed as a collaborator to lead sponsor V-Wave Ltd. The study will test the V-Wave Ventura Interatrial shunt, intended to reduce excessive left-sided cardiac filling pressures in patients with advanced Heart Failure with reduced Ejection Fraction (HFrEF).3 The trial is not yet recruiting, with an estimated start date of 2026-09-303, and plans to enroll approximately 250 patients3 in a 3:2 randomized design between shunt treatment and a non-implant placebo-procedure control group.3
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.