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Media Release / Jan 05, 2024

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…
Media 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-normal (≥…
Media 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…
Media Release / 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

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…
Media Release / Nov 24, 2023

Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to Crystallization

Company Contact: Novartis Pharmaceuticals Corporation 1-888-669-6682 Novartis Media Relations E-mail: [email protected] North America Julie Masow …
Media 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…
Media 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 resolved1Novartis capacity to produce Pluvicto will continue to grow with anticipated expansions to the manufacturing network in the US and globally…
Media 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…
Media Release / Oct 06, 2023

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…
Media Release / Sep 11, 2023

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to Crystallization

Company Contact: Novartis Pharmaceuticals Corporation 1-888-669-6682 EAST HANOVER, N.J., Sept. 11, 2023 -- Novartis is conducting a voluntary nationwide recall at the consumer level of one lot…

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