Basel, September 12, 2018 – Novartis today announced that The New England Journal of Medicine (NEJM) has published full results from the landmark Phase III Gilenya® (fingolimod) PARADIGMS study, the first-ever controlled, randomized study specifically designed for children and adolescents (aged 10 to 17) with relapsing forms of MS (RMS). Children and adolescents with MS experience …
Tag Archives: Gilenya
September, 2018
May, 2018
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14 May
FDA Approves Novartis’ Gilenya for Pediatric Patients with Relapsing Multiple Sclerosis
Basel, May 11, 2018 – Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for these patients[2]. This …
December, 2017
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18 December
FDA Grants Breakthrough Therapy Designation to Novartis’ Fingolimod for Pediatric Multiple Sclerosis
EAST HANOVER, N.J., Dec. 18, 2017 /PRNewswire/ — Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for fingolimod for the treatment of children and adolescents 10 years of age or older with relapsing multiple sclerosis (MS). Fingolimod, also known as Gilenya® in …
October, 2016
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26 October
Diving Deeper with Oral MS Medications
Over the past few years, new oral medications for multiple sclerosis have gained Food and Drug Administration (FDA) approval, giving patients treatment options beyond injectable forms of medication. With multiple sclerosis (MS) medications, one of the primary goals is to extend the time between relapses, which is why these medications …
December, 2015
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14 December
Akaal Pharma’s Drug Candidate Demonstrates Superior Safety & Comparable Efficacy Compared to Gilenya for Treatment of MS
MELBOURNE, Australia & SAN DIEGO–(BUSINESS WIRE)–Akaal Pharma, a clinical-stage drug discovery and development company, today announced the publication of preclinical studies of safety and efficacy of its novel small molecule drug candidate AKP-11 in comparison with Gilenya (Fingolimod, FTY-720). Gilenya is a FDA approved oral drug for the treatment of …