Filspari Granted Accelerated Approval to Reduce Proteinuria in IgA Nephropathy
Sparsentan is an endothelin and angiotensin II receptor antagonist.
Diagnosis & Disease Information
Jesduvroq Approved for Anemia of CKD in Patients on Dialysis
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
FDA Panel Votes on Tenapanor for Hyperphosphatemia in CKD
For patients who tolerated and remained on therapy, the average treatment effect on serum phosphorus was about -0.7mg/dL.
Empagliflozin Cuts Risk of Kidney Disease Progression, CV Death in CKD Patients
The EMPA-KIDNEY trial enrolled more than 6600 patients 18 years of age and older with CKD at risk of kidney disease progression.
FDA Needs Additional Time to Review Sparsentan, Tofersen Applications
The target action dates have been extended by 3 months to allow for extra time to review the applications.
Vaginal pH Modulator Misses Primary Endpoint in STI Clinical Trial
Topline results were announced from a phase 3 trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women.
Oxlumo Indication Expanded to Include Patients With Advanced PH1
The approval was based on data from the phase 3 ILLUMINATE-C study that included 21 dialysis-independent and -dependent patients with PH1.
FDA Approves Oral Testosterone Replacement Therapy Kyzatrex
The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.
Bludigo Approved as Diagnostic Dye for Cystoscopic Assessment of Ureters
The approval was based on data from a phase 3 study that included 118 adults undergoing endoscopic urological or gynecological surgical procedures.
FDA Cracks Down on Honey-Based Products Tainted With Undeclared Drugs
The products were being promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
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