Novartis
Basel, Switzerland
East Hanover, New Jersey, United States
with other locations globally
United States
Website: https://www.novartis.com/
2194 articles about Novartis
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Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis
1/5/2024
Novartis announced today that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, United States.
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The Swiss pharma is looking to leverage Voyager Therapeutics’ capsid technology for gene therapies aimed at treating Huntington’s disease and spinal muscular atrophy.
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The Biden administration on Thursday said 48 drugs covered under Medicare’s Part B may be subject to inflation rebates in the first quarter of 2024 under the Inflation Reduction Act.
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Novartis’ Iptacopan Aces Phase III Study in Ultra-Rare Kidney Disease Days After FDA Approval
12/12/2023
The trial demonstrated that C3G glomerulopathy patients treated with the oral factor B inhibitor saw a significant reduction in protein in their urine. The results come days after iptacopan won the FDA’s green light for a rare blood disease. -
Novartis presents new 48-week results from Phase III APPLY-PNH trial showing sustained efficacy and long-term safety of Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH)
12/11/2023
Novartis announced results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta® in adults with paroxysmal nocturnal hemoglobinuria who had residual anemia despite previous anti-C5 therapy.
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Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions - December 8, 2023
12/8/2023
Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients.
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Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions
12/8/2023
Novartis today announced results from an updated invasive disease-free survival (iDFS) analysis of the pivotal Phase III NATALEE trial, with a median follow-up of 33.3 months and following Kisqali® (ribociclib) treatment completion by 78.3% of patients.
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The Swiss pharma’s Fabhalta, a Factor B inhibitor, is the first FDA-approved oral monotherapy for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria.
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Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH
12/6/2023
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)1.
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The Swiss pharma is adopting a more streamlined strategy focusing on core therapeutic areas: cardiovascular, immunology, neuroscience and oncology, as well as renal and metabolic diseases.
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The agency on Tuesday said it is investigating the “serious risk” of T cell malignancy outcomes, including hospitalization and death, and evaluating the need for potential regulatory action.
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Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to Crystallization
11/24/2023
Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing.
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Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH
11/20/2023
Novartis will present data from over 100 trials across its breast cancer and hematology portfolios at the 2023 San Antonio Breast Cancer Symposium and the American Society of Hematology Annual Meeting & Exposition.
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After success with J&J, Legend strikes another license agreement, this one with Swiss pharma Novartis around CAR-T therapies.
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For $80 million upfront and the promise of more than $1.2 billion in milestones, Novartis has bought the global rights to develop an oral HDAC6 inhibitor from Chong Kun Dang Pharmaceutical.
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The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.
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Following the recent Chinook Therapeutics acquisition, the Novartis experimental IgA nephropathy therapeutic atrasentan significantly reduced protein in the urine of patients compared to placebo.
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Merck and Novartis beat expectations this week with solid third-quarter financial results, while BMS, Sanofi and Takeda spooked investors with negative near- and mid-term projections.
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Pluvicto improved radiographic progression-free survival in PSMA-positive patients with metastatic castration-resistant prostate cancer who had not been treated with taxane-based chemotherapy.
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The Swiss pharma reported a 12% sales increase and 21% core operating growth for the third quarter on Tuesday, while raising its full-year earnings forecast for the third time.