Genito Urinary System And Sex Hormones

Travere signs $120m licensing deal with Renalys for sparsentan in Asia

Travere Therapeutics has signed a licensing agreement for sparsentan with Japan-based Renalys Pharma for multiple Asian countries. As per the…

Novartis eyes label expansion for PNH drug

Novartis plans to discuss the filing of its drug iptacopan in C3 glomerulopathy with global health authorities on the back…

Ipsen and Genfit secure FDA priority review for chronic liver disease drug

Ipspen and Genfit’s elafibranor has received priority review designation from the US Food and Drug Administration (FDA) for the treatment…

Travere downsizes after a failed bid for sparsentan label expansion

Travere Therapeutics has implemented a 20% reduction of its workforce to funnel resources into Filspari’s (sparsentan) launch in IgA nephropathy…

Xphozah wins orphan drug designation for paediatric hyperphosphatemia

The US Food and Drug Administration (FDA) has granted an orphan drug designation to Ardelyx’s Xphozah (tenapanor) for the treatment…

I-Mab and HI-Bio gain breakthrough therapy designation for PMN therapy

I-Mab and HI-Bio have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for the investigational CD38…

Ardelyx wins FDA approval for phosphate absorption inhibitor

The US Food and Drug Administration (FDA) approved Ardelyx’s Xphozah (tenapanor) as an add-on therapy for CKD patients on dialysis…

Novo Nordisk gains FDA approval for primary hyperoxaluria therapy

Novo Nordisk has received approval from the US Food and Drug Administration (FDA) for Rivfloza (nedosiran) by injection to reduce urinary…

Novartis eyes accelerated FDA approval for iptacopan across multiple indications

Novartis has announced positive interim results for iptacopan from the Phase III Applause-IgAN study showing significant proteinuria reduction in patients…

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