IgA Nephropathy
Sep 02, 2025
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s; Travere Therapeutics Gains FDA Nod for FILSPARI REMS Update in IgA Nephropathy; Vanda Pharmaceuticals’ VGT-1849B Granted FDA Orphan Drug Status for Polycythemia Vera; Teva Launches First FDA-Approved Generic SAXENDA for Weight Loss; Sanofi’s WAYRILZ Gets FDA Approval as First BTK Inhibitor for Immune Thrombocytopenia
FDA Approves Eisai & Biogen’s LEQEMBI IQLIK for Maintenance Treatment of Early Alzheimer’s Eisai Co., Ltd. and Biogen Inc. announced that the FDA has approved the Biologics License Application (BLA) for LEQEMBI IQLIK (lecanemab-irmb), a once-weekly 360 mg subcutaneous autoinjector designed for maintenance do...
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Jun 20, 2025
Advancements in IgA Nephropathy (IgAN) Treatment: From Standard-of-care (SoC) to Emerging Therapies
IgA Nephropathy (IgAN): Pathogenesis and the Need for Targeted Therapies IgA nephropathy is a complex autoimmune disorder characterized by the accumulation of galactose-deficient IgA1 antibodies in the glomeruli, triggering a cascade of immune responses that ultimately lead to chronic kidney damage. Driven by a ...
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Apr 08, 2025
Amgen’s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis’ Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen’s BIIB080 Earns Fast Track for Alzheimer’s; Epicrispr’s EPI-321 Cleared by FDA for FSHD
Amgen’s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affec...
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Sep 16, 2024
Travere’s FILSPARI Approval Sparks Rivalry in the IgA Nephropathy Space
A year after failing to meet a trial endpoint, Travere Therapeutics can now relax. On 05 September 2024, the FDA upgraded FILSPARI’s conditional approval for the kidney disease IgA nephropathy to full approval. FILSPARI’s complete approval broadens its use, permitting the small molecule blocker to help slow kidn...
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Sep 10, 2024
Biogen’s SPINRAZA Phase II/III Trial Results; Travere’s FILSPARI FDA Approval; GSK’s NUCALA Succeeds in COPD Trial; Summit’s NSCLC Win Over KEYTRUDA Raises Caution; FDA Lifts Hold on RZ358 for Congenital Hyperinsulinism
Biogen's Higher SPINRAZA Dose Shows Improved Efficacy in Phase II/III Trial A trial studying a higher dose of Biogen’s spinal muscular atrophy drug SPINRAZA (nusinersen) has met the primary endpoint in a cohort of infants with SMA. The Phase II/III DEVOTE study, which included 145 patients across various ages an...
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Aug 27, 2024
Merck’s WINREVAIR™ EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant’s Borealis Launched; Moderna’s RSV mRESVIA® EU Approval; FDA Nods RYBREVANT® and LAZCLUZE™ for EGFR-mutated Lung Cancer
Merck’s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III Merck has secured European Commission (EC) approval for WINREVAIR™ (sotatercept), marking it as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved across all 27 EU me...
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Aug 19, 2024
Novartis’ FABHALTA: Leading the Way as the First Complement Inhibitor for IgAN
The first horse bearing Novartis’ IgAN treatment has reached the FDA’s approval milestone. FABHALTA is approved for use in treating IgAN patients who are at risk of swift disease progression, as evidenced by a urine protein-to-creatinine ratio of 1.5 g/g or higher. On August 8, the FDA approved the use of Novart...
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Jul 22, 2024
4 Late-Stage IgA Nephropathy Treatment Drugs to Look Out
Conventional IgA nephropathy treatments include ACE inhibitors (angiotensin-converting enzyme inhibitors) and ARBs (angiotensin II receptor blockers) to manage symptoms like high blood pressure. The only two FDA-approved treatments for managing IgAN are TARPEYO/KINPEYGO (budesonide) and FILSPARI (sparsentan)....
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Apr 16, 2024
Roche’s Columvi Phase III STARGLO Trial; Novartis’ Fabhalta Latest Data; Vertex’s Alpine Immune Sciences Acquisition; Telix Pharmaceuticals’ TLX101-CDx Fast Track Designation; NovelMed’s NM5072 Orphan Drug Designation
Roche's Columvi Achieves Primary Endpoint of Prolonged Overall Survival in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Trial Roche reported that the Phase III STARGLO trial successfully achieved its main goal of improving overall survival. The research revealed that in...
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Mar 12, 2024
BeiGene’s BRUKINSA Gets FDA Accelerated Approval; GSK’s Positive Results in DREAMM-8 Phase III; Sandoz’s Denosumab Biosimilars FDA Approved; Terns Pharma’s TERN-701 Receives Orphan Drug Designation; Wegovy® Approved in US for Overweight Cardiovascular Risk; Travere Therapeutics Submits sNDA for FILSPARI IgAN Full Approval
BeiGene Receives FDA Accelerated Approval for BRUKINSA in Relapsed/Refractory Follicular Lymphoma BeiGene, Ltd., has declared that the FDA has provided accelerated approval for BRUKINSA® (zanubrutinib) to be used in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), when used alo...
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