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Key Release / Oct 04, 2023

Novartis executes Sandoz Spin-off, completing strategic transformation into a leading, focused innovative medicines company

Ad hoc announcement pursuant to Art. 53 LR Novartis executes separation of the Sandoz business to create an independent company by way of a 100% Spin-offShares of Sandoz will be listed and…
Press Release / Oct 05, 2023

Novartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer

Key data from the Phase III PSMAfore trial has been selected for a Presidential session; PSMAfore is investigating PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan) in the pre-chemotherapy…
Key Release / Oct 02, 2023

Novartis investigational iptacopan 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 APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria…
Press Release / Sep 18, 2023

Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab

Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical dataBreast and gastric cancers are among most common types of cancer, accounting together for nearly half…
Press Release / Sep 25, 2023

Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Phase III NETTER-2 trial met primary endpoint of improvement in progression-free survival (PFS) and key secondary endpoint of objective response rate (ORR) in patients with Grade 2 and 3 advanced…
Press Release / Sep 26, 2023

Sandoz receives European Commission approval for Tyruko® (natalizumab), first and only biosimilar for multiple sclerosis in Europe

Biosimilar Tyruko® approved for all indications of reference medicine, as first and only biosimilar to treat relapsing forms of multiple sclerosis (MS) in EuropeDecision based on evidence from…
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…
Press Release / Oct 20, 2023

Novartis Kisqali® NATALEE analysis reinforces consistent reduction in risk of recurrence across key subgroups of patients with early breast cancer

Late-breaking NATALEE subgroup analysis to be presented at ESMO shows invasive disease-free survival (iDFS) benefit remains consistent in all subgroups, including in patients with stage II tumors,…
Press Release / Oct 23, 2023

Novartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane setting

Phase III PSMAfore trial with Pluvicto™ met its primary endpoint of radiographic progression-free survival (rPFS) with a HR of 0.411; Pluvicto more than doubled median rPFS to 12.0 months per updated…