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June 2020
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Media ReleaseNovartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosisBasel, June 2, 2020 — Novartis today announced that it has received notice from the US Food and Drug Administration (FDA) that the agency has extended its review of the Supplemental Biologics…
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Media ReleaseAveXis Community Statement on the Global Managed Access Program for AVXS-101Dear SMA community, In January we launched a global Managed Access Program (MAP) for Zolgensma® (onasemnogene abeparvovec). Under this program, we are making up to 100 doses available in 2020 to…
May 2020
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Media ReleaseNovartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar® + Mekinist® following surgeryMore than half of patients with BRAF-mutated advanced melanoma taking Tafinlar + Mekinist were alive and free of a relapse at 5-years1 Study conclusions are drawn from the largest dataset and…
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Media ReleaseNovartis Piqray® receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutationPiqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast cancer patients whose tumors harbor a PIK3CA mutation in Europe Phase III…
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Media ReleaseNovartis data highlight benefit of early treatment initiation in patients with secondary progressive multiple sclerosis (SPMS)Novartis presented a total of 34 abstracts at the Congress of the European Academy of Neurology (EAN), emphasizing its strong multiple sclerosis (MS) portfolio with 20 abstractsLong-term efficacy…
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Media ReleaseNovartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive diseaseNew MONALEESA-7 (M7) and MONALEESA-3 (M3) subgroup analysis to be presented during ASCO20 Virtual Scientific Program Subgroup analysis shows Kisqali plus endocrine therapy extended life…
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Media ReleaseNovartis announces new late-breaking ofatumumab data at EAN demonstrating robust efficacy and safety in the treatment of relapsing forms of multiple sclerosis (RMS)Rapid and profound depletion of B-cells contributed to a halt in disease activity in RMS patients1 A post hoc analysis showed 47.0% and 87.8% of patients treated with ofatumumab achieved no…
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Media ReleaseNovartis study reveals that migraine support in the workspace can significantly decrease the impact of the disease on affected employeesThe patients that completed the Migraine Care pilot program reported over 50% reduction in migraine disability and a significant improvement in their patient activation measure after six months …
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Media ReleaseAveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)Zolgensma® (onasemnogene abeparvovec) is conditionally approved in Europe for the treatment of patients with spinal muscular atrophy (SMA) and a clinical diagnosis of SMA Type 1; or SMA patients with…
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Media ReleaseNovartis data at ASCO and EHA showcase bold approaches to reimagine cancer and blood disorders through multiple therapeutic platformsNew Kisqali® (ribociclib)* overall survival subgroup analysis in HR+/HER2- advanced breast cancer (ABC) and additional Piqray® (alpelisib) data in patients in HR+/HER2- ABC patients with a PIK3CA…
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Key ReleaseNovartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14Tabrecta (capmatinib, formerly INC280) is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation that leads to MET exon 14 skipping (METex14)…
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Media ReleaseNovartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthmaCHMP positive opinion advances efforts to provide first-in-class LABA/LAMA/ICS combination for patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment in the EU. Digital…
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