Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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February 2023
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Media ReleaseNovartis announces the appointment of the Chairman-Designate of Sandoz Board of DirectorsGilbert Ghostine, CEO of the Swiss multi-national fragrances business Firmenich appointed Chairman-Designate of the future Sandoz BoardMr Ghostine to begin role as Sandoz Chairman following the spin-…
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Media ReleaseSandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDASubmission supported by comprehensive analytical and clinical data package Denosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2 Sandoz…
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Media ReleasePatients with hidradenitis suppurativa experienced sustained efficacy and symptom improvement at one year when treated with Novartis Cosentyx®In two of the largest Phase III trials conducted in hidradenitis suppurativa (HS), Cosentyx® (secukinumab) treatment response rates continued to improve beyond the primary endpoint analysis at Week…
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Key ReleaseNovartis continues to grow with further core margin expansion and achieves important innovation milestonesAd hoc announcement pursuant to Art. 53 LR Full year Net sales grew +4% (cc1, -2% USD) with core operating income growing +8% (cc, 0% USD) IM sales grew +4% (cc, -2% USD) and core operating income…
January 2023
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Media ReleaseSandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilarSandoz is seeking approval of high concentration formulation (HCF) adalimumab for use in all indications of reference medicine Upon approval, HCF formulation will offer patients enhanced yet familiar…
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Media ReleaseSandoz announces agreement to acquire leading antifungal agent Mycamine® from Astellas, reinforcing hospital offering and leading Anti-Infectives portfolioSandoz plans to acquire worldwide product rights for Mycamine® (micafungin sodium) from AstellasAcquiring leading global echinocandin, one of three major antifungal classes, will significantly…
December 2022
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Media ReleaseNovartis presents pivotal Phase III APPLY-PNH data at ASH demonstrating investigational oral monotherapy iptacopan superiority over anti-C5Trial met both primary and most secondary endpoints, showing iptacopan provided transfusion-free hemoglobin-level increases in vast majority of adult paroxysmal nocturnal hemoglobinuria (PNH)…
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Media ReleaseNovartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancerEC 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…
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Media ReleaseNovartis investigational iptacopan provides clinically meaningful increases in hemoglobin levels in complement-inhibitor-naïve patients with PNHPhase III APPOINT-PNH study of investigational oral monotherapy iptacopan met its primary endpoint; second positive Phase III topline readout for iptacopan in paroxysmal nocturnal hemoglobinuria (PNH…
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Media ReleaseNovartis Kisqali® prolonged PFS benefit for pre- and perimenopausal patients with aggressive HR+/HER2− metastatic breast cancer compared to chemotherapyRIGHT Choice Phase II trial is the first randomized study in patients with aggressive HR+/HER2− metastatic breast cancer (MBC), including visceral crisis, comparing a CDK4/6 inhibitor (CDK4/6i) plus…
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Key ReleaseNovartis Pluvicto™ shows statistically significant and clinically meaningful radiographic progression-free survival benefit in patients with PSMA–positive metastatic castration-resistant prostate cancerAd hoc announcement pursuant to Art. 53 LR Phase III PSMAfore trial with PluvictoTM met the primary endpoint of radiographic progression-free survival (rPFS) in PSMA–positive mCRPC who have been…
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