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January 2018
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Media Release
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… -
Media Release
Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
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Media Release
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… -
Media Release
Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer
December 2017
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Media Release
Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
- Breakthrough Therapy designation can expedite the development and review of therapies for serious conditions(1)- In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82%… -
Media Release
Novartis multiple sclerosis therapy fingolimod granted FDA Breakthrough Therapy designation for pediatric MS
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Media Release
Novartis drug crizanlizumab shown to prolong time to patients' first sickle cell pain crisis in subgroup analysis of SUSTAIN study
- Investigational therapy crizanlizumab (SEG101, formerly SelG1) approximately doubled the time to first on-treatment sickle cell pain crisis, according to new subgroup analysis of Phase II SUSTAIN… -
Media Release
Novartis drug crizanlizumab shown to prolong time to patients' first sickle cell pain crisis in subgroup analysis of SUSTAIN study
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Media Release
Primary analysis results from Novartis pivotal JULIET trial show Kymriah™ (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer
- At six months, 30% of patients treated with Kymriah were in complete response, with a 74% relapse-free rate after onset of response; median duration of response was not reached- Grade 3/4… -
Media Release
Primary analysis results from Novartis pivotal JULIET trial show Kymriah™ (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer
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Media Release
Novartis initiates study evaluating impact of higher dosing of Cosentyx® in patients with ankylosing spondylitis
- ASLeap trial to evaluate impact of increasing the dose of Cosentyx (secukinumab) to 300 mg in patients who do not achieve symptom remission after 16 weeks of treatment with the approved dose of 150… -
Media Release
Novartis initiates study evaluating impact of higher dosing of Cosentyx® in patients with ankylosing spondylitis
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