Xeltis wins FDA breakthrough status, enrols first patient in pivotal trial
Xeltis has hit two milestones for its vascular access conduit, with one coming in the regulatory arena and the other…
Genito Urinary System And Sex Hormones
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Astella’s iota receives FDA go-ahead for bladder implant trial
Astellas Pharma subsidiary, iota Biosciences, has won an investigational device exemption (IDE) from the US Food and Drug Administration (FDA)…
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Resolution scores $83m to develop macrophage cell therapies
Resolution Therapeutics has raised £63.5m ($83.3m) in a Series B financing round to develop its macrophage cell therapies. The UK-based…
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Neuspera eyes FDA approval for urinary incontinence implant
Neuspera Medical has announced that its implantable sacral neuromodulation (SNM) system for treating urinary urge incontinence has met the primary…
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Novo Nordisk’s ocedurenone Phase III flop costs company $816m
Novo Nordisk has said it will take a DKr5.7bn ($816m) hit after its acquired drug ocedurenone flopped in the Phase…
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Contraline’s male contraceptive device trial gets sperm analysis collab
DNA Diagnostics Centre (DDC) will supply a home test kit for sperm detection to Contraline’s first-in-human trial evaluating its male…
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Signati kicks off trial investigating quicker vasectomy device
Signati Medical has enrolled the first patient in a clinical trial investigating its device designed to quicken vasectomy procedures. The…
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Affluent implants artificial sphincter in urinary incontinence study
French company Affluent Medical has completed the first successful implantation of its Artus device for the treatment of urinary incontinence.…
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SeaStar’s device granted humanitarian exemption approval for children with AKI
Following positive clinical results, the US Food Drug Administration (FDA) has granted SeaStar Medical a humanitarian device exemption (HDE) approval…
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Travere signs $120m licencing deal with Renalys for sparsentan in Asia
Travere Therapeutics has signed a licencing agreement for sparsentan with Japan-based Renalys Pharma for multiple Asian countries. As per the…
