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Press Release / Jan 16, 2018

Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA

Adalimumab is an anti-TNF medicine used to treat a range of immunological diseases[1] The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab…
Ad-hoc Releases / Jan 11, 2018

Novartis appoints Elizabeth Barrett as Oncology Head

Novartis appoints experienced pharmaceuticals industry leader with strong marketing skills to drive oncology business further Novartis appoints ad interim leader for its Global Drug Development…
Ad-hoc Releases / Jan 11, 2018

Novartis ernennt Elizabeth Barrett zur Chefin Onkologie

Novartis ernennt eine erfahrene Pharma-Führungskraft mit starken Marketingfähigkeiten, um das Onkologiegeschäft weiter zu entwickeln Novartis ernennt ad interim Leiter für die Global Drug…
Press Release / Jan 09, 2018

Novartis advances head-to-head superiority trials of Cosentyx® versus Humira®* and proposed biosimilar adalimumab**

SURPASS is the first head-to-head superiority trial versus proposed biosimilar adalimumab** in ankylosing spondylitis (AS)[1] EXCEED is the first head-to-head superiority trial…
Press Release / Jan 08, 2018

REGENXBIO and AveXis Announce Expansion of Relationship through Amended License Agreement for the Development and Commercialization of Treatments for Spinal Muscular Atrophy

AveXis acquires exclusive rights to entire NAV Technology Platform for the development of treatments for SMA Amended agreement permits assignment by AveXis upon a change of control…
Press Release / Jan 04, 2018

AveXis Announces Alignment with FDA on Next Steps Toward a BLA Submission for AVXS-101 in SMA Type 1

– Company to submit information requested by FDA to the IND on an on-going basis – – AveXis plans to request a pre-BLA meeting in Q2 2018 – – Conference call and webcast today at 4:…
Press Release / Jan 04, 2018

Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)

Data supporting designation showed over half of treatment-naïve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of…
Press Release / Jan 03, 2018

Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer

Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal…
Press Release / Dec 22, 2017

Novartis drug Tasigna® is approved by FDA as first and only CML therapy with Treatment-free Remission data in its label

Inclusion of Treatment-free Remission (TFR) data provides additional and novel option in management of Ph+ CML-CP Deep and sustained molecular response included as key eligibility criteria…
Press Release / Dec 22, 2017

Novartis' combination therapy Tafinlar® + Mekinist® granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma

Priority Review designation based on Phase III study showing 53% reduction in risk of recurrence or death with Tafinlar + Mekinist, as compared to placebo[1] Improvements observed in key…

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