IgA Nephropathy

Sep 16, 2024

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...

Sep 10, 2024

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...

Aug 27, 2024

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...

Aug 19, 2024

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...

Jul 22, 2024

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)....

Apr 16, 2024

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...

Mar 12, 2024

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...

Oct 03, 2023

AbbVie Presents Results from Phase III CANOVA Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma AbbVie has released findings from its Phase III CANOVA trial, which assessed the safety and effectiveness of venetoclax (marketed as VENCLEXTA®/VENCLYXTO®) in combination with dexamethasone ...

Mar 14, 2023

Sanofi to Acquire Provention Bio for USD 2.9 Billion Sanofi and Provention Bio, Inc., a publicly traded biopharmaceutical company based in the United States focused on intercepting and preventing immune-mediated diseases such as type 1 diabetes (T1D), have agreed to acquire Provention Bio, Inc. for $25.00 per sh...

Nov 05, 2021

IgA Nephropathy (IgAN), also called Berger’s disease, is an autoimmune rare disease affecting the kidneys. It impairs blood filtration in the kidneys' tiny blood channels. An aberrant protein destroys the filtering unit (glomerulus) inside the kidneys, causing IgA Nephropathy. It is estimated that 20–40% of persons...