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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…
Ad hoc 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…
Ad hoc 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 / 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 / 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…
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 / 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 / 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…