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Press Release / Dec 11, 2023

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)

APPLY-PNH extension data show that continuous Fabhalta® (iptacopan) treatment in adults with paroxysmal nocturnal hemoglobinuria (PNH) enabled sustained hemoglobin-level increases to near-…
Press Release / Dec 08, 2023

Latest Novartis Kisqali® NATALEE analysis reinforces 25% reduction in risk of recurrence across broad population of patients with early breast cancer; supports regulatory submissions

With 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…
Ad-hoc Releases / Dec 06, 2023

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

Ad 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…
Ad-hoc Releases / Nov 28, 2023

Novartis upgrades mid-term sales growth guidance, showcases its differentiated innovative medicines strategy and robust pipeline at R&D Day

Ad 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…
Press Release / Nov 20, 2023

Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH

Late-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-…
Press Release / Nov 09, 2023

Novartis data show potential of remibrutinib as an oral treatment for chronic spontaneous urticaria providing significant symptom improvement as early as Week 2

In pivotal Phase III trials, remibrutinib – a highly selective, oral Bruton’s tyrosine kinase inhibitor – demonstrated clinically meaningful and statistically significant reduction in urticaria…
Press Release / Oct 31, 2023

FDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade

FDA 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…
Ad-hoc Releases / Oct 30, 2023

Novartis 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;…
Press Release / Oct 26, 2023

Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers

US 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…
Ad-hoc Releases / Oct 24, 2023

Novartis delivers 12% sales and 21% core operating income growth from continuing operations (in cc¹). Executes Sandoz spin-off, achieves important innovation milestones, and raises FY 2023 guidance

Ad hoc announcement pursuant to Art. 53 LR Transformation into a “pure-play” innovative medicines business is complete, with the spin-off of Sandoz; commentary below is on continuing…

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