Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Shots: The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…

ByRidhi RastogiJuly 17, 2026

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Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka reported the ongoing P-III (VISIONARY) trial data assessing Voyxact (sibeprenlimab; n= 320) vs PBO (n=152) in preserving kidney function in IgAN pts over a 24mos. treatment period At 12mos., Voyxactimproved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², achieving the KDIGO treatment goal of limiting annual kidney…

ByRidhi RastogiJune 5, 2026

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ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Shots: ClearNote Health has received the UKCA certification for its Avantect Multi-Cancer & Ovarian Cancer tests to detect multiple cancers & support early diagnosis of ovarian cancer, respectively The Multi-Cancer Detection Test screens multiple cancers from a simple blood sample using 5-hydroxymethylcytosine & genomic biomarkers in cell-free DNA, & was selected for the NCI-funded Vanguard…

ByRidhi RastogiSeptember 25, 2025

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Hansa Biopharma Reports Topline P-III (ConfIdeS) Trial Data of Imlifidase in Kidney Transplantation

Shots: Hansa Biopharma has reported topline P-III (ConfIdeS) trial data assessing imlifidase vs control for 12mos. in 64 kidney transplant pts (cPRA ≥99.9%) across 25 US sites Trial met its 1EP of improved kidney function at 12mos. per mean eGFR, with pts achieving eGFR of 51.5 mL/min/1.73m2 vs 19.3 mL/min/1.73m2, plus reached statistical significance in…

ByRidhi RastogiSeptember 25, 2025

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The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function

Shots: The US FDA has approved MediBeacon TGFR to assess patients with normal or impaired renal function The system met FDA-approved 1EP of 94% P30 value (% of GFR estimates within ±30% of mGFR) in patients with varied GFR & skin tones. The approval aligns with recent data publication in support of Lumitrace in…

ByRidhi RastogiJanuary 21, 2025

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Hansa Biopharma Reports Topline P-III (ConfIdeS) Trial Data of Imlifidase in Kidney Transplantation

The US FDA Approves Innovate’s MediBeacon Transdermal GFR System to Evaluate Renal Function

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