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Ad hoc release / Sep 30, 2025

Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)

Ad hoc announcement pursuant to Art. 53 LR Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering unique approach to CSU treatment1Well-controlled…
Press release / Feb 26, 2016

FDA approves new indication for Novartis drug Afinitor® for progressive, nonfunctional GI and lung neuroendocrine tumors (NET)

In advanced progressive, nonfunctional NET, Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET Approval helps fulfill unmet need as…
Press release / Jun 01, 2023

Novartis receives European approval for Cosentyx® as first and only IL-17A inhibitor for hidradenitis suppurativa

Cosentyx® (secukinumab) is the first new biologic treatment for hidradenitis suppurativa (HS) in nearly a decade, offering clinically meaningful results across the most debilitating symptoms1,2…
Press release / Dec 13, 2022

Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer

EC approval based on results from pivotal Phase III VISION trial, in which Pluvicto® plus best standard of care (BSoC) significantly improved overall survival and radiographic progression-free…
Ad hoc release / Apr 03, 2025

Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN)

Ad hoc announcement pursuant to Art. 53 LR Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation…
Ad hoc release / Aug 08, 2024

Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)

Ad hoc announcement pursuant to Art. 53 LR Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm,…
Press release / Apr 07, 2016

Novartis receives EU approval for Revolade® as first-in-class therapy for children aged 1 year and above with chronic ITP

EU approval of Revolade expands treatment options for pediatric patients aged 1 year and above with chronic ITP who have not responded to other therapies Two formulations approved: once-daily…
Ad hoc 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

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…
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 / Aug 25, 2023

Sandoz receives FDA approval for Tyruko® (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis

Biosimilar Tyruko® approved for all indications of reference medicine, with same dosing and administration schedule Sandoz continues to expand access to much-needed medications for patients…

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