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January 2024
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Media Release
Novartis Lutathera® significantly reduced risk of disease progression or death by 72% as first-line treatment for patients with advanced gastroenteropancreatic neuroendocrine tumors
In the Phase III NETTER-2 trial, Lutathera plus octreotide LAR significantly extended median PFS to 22.8 months vs. 8.5 months with high-dose octreotide LAR in patients with newly diagnosed grade 2… -
Media Release
Novartis expands production of Pluvicto® with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis
FDA approval of the company’s second US Radioligand Therapy (RLT) manufacturing facility increases RLT production capacity to 250,000 doses in 2024 and beyond New 70,000-square foot RLT facility…
December 2023
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Media Release
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-normal (≥… -
Media Release
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… -
Media Release
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
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 inhibitor-naïve patients1-5 In APPLY-PNH…
October 2023
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Media Release
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… -
Media Release
Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers
US FDA has classified drug shortage status as resolved1Novartis capacity to produce Pluvicto will continue to grow with anticipated expansions to the manufacturing network in the US and globally… -
Media Release
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… -
Media Release
FDA approves Novartis Cosentyx® as first intravenous (IV) formulation interleukin-17A antagonist for rheumatic diseases
First new intravenous (IV) treatment option in six years for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)1-6 Cosentyx…