February 2026
January 2026
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Press release
Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s diseaseDesignation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1Distinction expedites development and review of treatments for serious…
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Press release
Novartis to add radioligand therapy manufacturing facility in Winter Park, Florida, fourth in US to serve patients and advance $23 billion investmentNew 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern USPurpose-built facility will strengthen Novartis RLT…
December 2025
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Press release
Novartis and US government reach agreement on lowering drug prices in the USNovartis agrees to take actions aimed at meeting US Administration priorities for drug pricingAdditional Novartis medicines will be made available through direct-to-patient platforms in 2026Company…
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Press release
Novartis ianalumab significantly extends disease control in patients with immune thrombocytopenia with only four once-monthly dosesIanalumab (9 mg/kg) plus eltrombopag extended ITP disease control by 45% with patients maintaining disease control 2.8 times longer than with placebo plus eltrombopag1,2 62% of patients treated with…
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Press release
1 in 4 metastatic breast cancer patients treated with Novartis Kisqali® remain progression-free beyond 4 yearsProgression-free response stayed consistent across age, BMI, and menopausal status in MONALEESA pooled analysis1 KISQALI is only CDK4/6i to demonstrate statistically significant overall survival (OS…
November 2025
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Press release
Novartis data underscore pioneering scientific innovation in hematology and oncology at ASH and SABCSPositive results from ianalumab pivotal Phase III trial in ITP patients previously treated with corticosteroids to be presented as late-breakerScemblix data across clinical and real-world settings…
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Ad hoc release
Novartis receives FDA approval for Itvisma®, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA)Ad hoc announcement pursuant to Art. 53 LR Itvisma (onasemnogene abeparvovec-brve) demonstrated improved motor function and stabilization in patients regardless of SMA treatment history in Phase III…
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Ad hoc release
Novartis projects +5-6% cc sales CAGR 2025-2030, with long-term growth backed by 30+ potential high-value pipeline assetsAd hoc announcement pursuant to Art. 53 LR Mid-term sales guidance rolled forward to +5-6% cc CAGR for 2025-2030, following upgrade of 2024-2029 guidance to +6% cc1Peak sales guidance upgraded for…
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Press release
Novartis announces plans to build flagship manufacturing hub in North CarolinaExpansion represents significant investment in North Carolina and is expected to create 700 new jobs in the state by end of 2030Enables manufacturing of medicines across company’s main therapeutic…
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Press release
Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistancePhase III trial for KLU156 (ganaplacide/lumefantrine, or GanLum), meets primary endpoint of non-inferiority to standard of care Coartem® (artemether-lumefantrine) Demonstrates PCR-corrected cure rate…
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Press release
Novartis opens new radioligand therapy manufacturing facility in California as part of $23B US expansion planCarlsbad location is company’s third US-based radioligand therapy (RLT) manufacturing site New site expands manufacturing footprint to meet future demand; ensures continued on-time delivery rate of…