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August 2020
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Media Release
Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma
Phase III COMBI-i trial did not meet primary endpoint for patients with advanced BRAF V600-mutated melanoma Tafinlar + Mekinist remains an effective treatment option based on previously reported… -
Key Release
FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple… -
Key Release
Novartis announces US District Court for the District of Delaware upholds validity of Gilenya® (fingolimod) dosage regimen patent
Basel, August 17, 2020 — Novartis welcomes the decision by the US District Court for the District of Delaware to uphold the validity of the Gilenya® (fingolimod) dosage regimen patent, as our… -
Media Release
Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps
EC approves Xolair® (omalizumab) as an add-on therapy for severe chronic rhinosinusitis with nasal polyps, the first anti-immunoglobulin E antibody approved in this indication1 Chronic… -
Media Release
Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis
Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis1… -
Media Release
Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma
Global ELARA trial demonstrated clinically meaningful benefit in patients with relapsed or refractory (r/r) follicular lymphoma (FL) as measured by complete response rate Kymriah previously… -
Media Release
Novartis Cosentyx® receives EU approval for first-line systemic treatment in pediatric psoriasis
EU approval is based on two Phase III studies showing Cosentyx® provides fast and strong skin clearance, along with significant improvement in quality of life and a favorable safety profile1 …
July 2020
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Media Release
Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation
Piqray (alpelisib) is the only treatment approved specifically to address PIK3CA mutation, underscoring Novartis commitment to reimagining cancer care Approval based on SOLAR-1 Phase III trial… -
Media Release
Sandoz announces plans for joint investment to help strengthen future of antibiotics manufacturing in Europe
Sandoz and Austrian government announce joint plans to drive long-term competitiveness of European production for key antibiotics in Europe Planned combined investment of more than EUR 150… -
Media Release
New Novartis analysis shows wet AMD patients achieved sustained fluid control faster with Beovu® versus aflibercept
A post-hoc analysis of the HAWK and HARRIER trials presented at ASRS showed >=50% of patients achieved sustained retinal dryness by weeks 8 and 4 with Beovu and by weeks 12 and 8 with aflibercept… -
Media Release
Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe CHMP opinion supported by data showing Adakveo significantly reduced the rate of vaso-… -
Media Release
Novartis announces Phase III study of Jakavi® in chronic graft-versus-host disease met primary and key secondary endpoints
Jakavi® demonstrated superior overall response rate in patients with chronic graft-versus-host disease (GvHD) compared to best available therapy, building on previous positive findings in acute GvHD1…
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