Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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August 2022
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Media ReleaseNovartis presents new data in breast and prostate cancer at ESMOOverall survival results from pooled exploratory analysis of MONALEESA trials in patients with aggressive HR+/HER2- advanced breast cancer treated with Kisqali® Data from VISION study reporting…
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Media ReleaseNovartis Scemblix®, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukemiaApproval based on results from pivotal Phase III ASCEMBL trial, in which Scemblix® (asciminib) nearly doubled the major molecular response rate vs. Bosulif®* (bosutinib) (25.5% vs. 13.2%) with a more…
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Key ReleaseNovartis announces intention to separate Sandoz business to create a standalone company by way of a 100% spin-offAd hoc announcement pursuant to Art. 53 LR Sandoz strategic review concludes that a separation of Sandoz by way of a 100% spin-off is in the best interest of shareholders, creating the…
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Media ReleaseNovartis provides update on Phase III CANOPY-A study evaluating canakinumab as adjuvant treatment in non-small cell lung cancerPhase III CANOPY-A trial did not meet primary endpoint of disease-free survival in patients with stages II-IIIA and IIIB completely resected non-small cell lung cancer1Findings will be…
July 2022
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Media ReleaseApplications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMASubmission of proposed biosimilar supported by comprehensive package; aims to expand treatment access for people with multiple sclerosis in US and EUMultiple sclerosis (MS) is a chronic inflammatory…
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Media ReleaseSandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF)Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study Proposed Hyrimoz® HCF would help expand access to medicine for patients with chronic…
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Key ReleaseNovartis delivers continued strong momentum of key growth brands, progress on strategic initiatives and confirms FY’22 Group guidanceAd hoc announcement pursuant to Art. 53 LR Q2 sales grew +5% cc1 (-1% USD) Innovative Medicines (IM) sales grew +5% cc (-1% USD); strong performance of key growth brands including Entresto (+33%…
June 2022
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Media ReleaseNew Phase III data show Novartis tislelizumab significantly extended median overall survival by more than 6 months in first-line advanced esophageal cancer in combination with chemotherapyFirst-line tislelizumab plus chemotherapy showed median overall survival of 17.2 months versus 10.6 months for chemotherapy and reduced risk of death by 34% in patients with advanced esophageal…
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Media ReleaseNovartis resumes production and delivery of radioligand therapy medicines ahead of scheduleProduction and phased deliveries of patient doses resumed in early June Screening and enrollment have restarted for 177Lu-PSMA-617 and Lutathera® clinical trials Expanding radioligand therapy…
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Media ReleaseNew Novartis extension phase data show nearly 80% of RMS patients treated with Kesimpta® (ofatumumab) had no evidence of disease activity (NEDA-3)New data from the Phase 3 ASCLEPIOS I/II trials and ALITHIOS open-label extension show that after four years nearly 8 out of 10 of people with relapsing multiple sclerosis (RMS) treated continuously…
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Media ReleaseCosentyx® (secukinumab) receives expanded approvals in EU for use in childhood arthritic conditionsApprovals based on data from the JUNIPERA trial, showing that Cosentyx® (secukinumab) reduced the risk of flare and disease activity compared to placebo over 2 years in pediatric patients1 with…
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