Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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January 2024
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Key ReleaseNovartis Scemblix® shows superior major molecular response (MMR) rates vs. standard‐of‐care TKIs in Phase III trial for newly diagnosed patients with chronic myeloid leukemiaMEDIA & INVESTOR RELEASE Novartis Scemblix® shows superior major molecular response (MMR) rates vs. standard-of-care TKIs in Phase III trial for newly diagnosed patients with chronic…
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Media ReleaseNovartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in IndianapolisFDA approval of the company’s second US Radioligand Therapy (RLT) manufacturing facility increases RLT production capacity to 250,000 doses in 2024 and beyondNew 70,000-square foot RLT facility is…
December 2023
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Key ReleaseNovartis investigational iptacopan Phase III study demonstrates clinically meaningful and statistically significant proteinuria reduction in patients with C3 glomerulopathy (C3G)Ad hoc announcement pursuant to Art. 53 LR Phase III APPEAR-C3G study met its primary endpoint, demonstrating superiority of iptacopan vs. placebo in proteinuria reduction at six-month analysis1;…
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Media ReleaseNovartis 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)APPLY-PNH extension data show that continuous Fabhalta® (iptacopan) treatment in adults with paroxysmal nocturnal hemoglobinuria (PNH) enabled sustained hemoglobin-level increases to near-…
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Media ReleaseLatest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissionsWith 5.6 months of additional follow-up and 78.3% of patients having completed Kisqali® (ribociclib) investigational treatment, the updated analysis shows sustained iDFS benefit and stability in…
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Key ReleaseNovartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNHAd hoc announcement pursuant to Art. 53 LR Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement…
November 2023
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Key ReleaseNovartis upgrades mid-term sales growth guidance, showcases its differentiated innovative medicines strategy and robust pipeline at R&D DayAd hoc announcement pursuant to Art. 53 LR ‘Pure-play’ innovative medicines strategy focused on four therapeutic areas and five technology platforms, which offer potential for consistent…
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Media ReleaseNovartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASHLate-breaking final iDFS analysis from NATALEE investigating Kisqali® (ribociclib) in broad population of patients with stage II and III HR+/HER2- early breast cancer, including those with node-…
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Media ReleaseNovartis data show potential of remibrutinib as an oral treatment for chronic spontaneous urticaria providing significant symptom improvement as early as Week 2In pivotal Phase III trials, remibrutinib – a highly selective, oral Bruton’s tyrosine kinase inhibitor – demonstrated clinically meaningful and statistically significant reduction in urticaria…
October 2023
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Media ReleaseFDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decadeFDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21 As the only IL-17A inhibitor…
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Key ReleaseNovartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN)Ad hoc announcement pursuant to Art. 53 LR Phase III ALIGN study met its primary endpoint, demonstrating superiority of atrasentan vs. placebo in proteinuria reduction at 36-week interim analysis1;…
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Media ReleaseNovartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centersUS FDA has classified drug shortage status as resolved1 Novartis capacity to produce Pluvicto will continue to grow with anticipated expansions to the manufacturing network in the US and globally…
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