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Multiple Sclerosis

FDA Accepts Celgene’s Application for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review …

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New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis

CAMBRIDGE, Mass., May 30, 2019 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced today new interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that the investigational treatment diroximel fumarate was generally well tolerated in people with relapsing multiple sclerosis (MS). These results were presented at the annual meeting of the …

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MediciNova Announces Results of Subgroup Analysis from the Phase 2b Trial of MN-166 (ibudilast) in Progressive MS

LA JOLLA, Calif., April 01, 2019 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced results from its subgroup analysis of the SPRINT-MS Phase 2b trial of MN-166 (ibudilast) in …

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FDA Approves Mavenclad Tablets as First and Only Short-Course Oral Therapy for Relapsing-Remitting and Active Secondary Progressive MS

ROCKLAND, Mass., March 29, 2019 /PRNewswire/ — EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved MAVENCLAD® (cladribine) tablets for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive …

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FDA Approves Novartis’ Mayzent, the First Oral Drug to Treat Secondary Progressive Multiple Sclerosis with Active Disease

EAST HANOVER, N.J., March 27, 2019 /PRNewswire/ — Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent® (siponimod) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS, is defined as a first episode of neurologic symptoms that lasts …

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Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with …

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Alkermes and Biogen Announce FDA Acceptance of Diroximel Fumarate NDA for Multiple Sclerosis

DUBLIN, Ireland and CAMBRIDGE, Mass., Feb. 25, 2019 (GLOBE NEWSWIRE) — Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing forms …

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Alkermes and Biogen Announce Submission of a NDA to the FDA for Diroximel Fumarate in Multiple Sclerosis

DUBLIN, Ireland and CAMBRIDGE, Mass., Dec. 17, 2018 (GLOBE NEWSWIRE) — Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098), a novel oral fumarate in development for the treatment of relapsing …

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Recent Survey Reveals that Multiple Sclerosis Patients Want More Information on Brain Atrophy

SUMMIT, N.J.–(BUSINESS WIRE)–A new survey examines the topic of brain volume loss, known as brain atrophy, in people with multiple sclerosis. The survey findings, presented at ECTRIMS 2018, suggest that there is a high level of interest in better understanding how brain atrophy may impact disease progression. Sixty-three percent of …

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Teva Presents 25-Year Safety Data from Longest Continuous Trial of Copaxone for Treatment of Relapsing Forms of Multiple Sclerosis

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced safety and tolerability results representing 25 years of data from the open-label extension study of the original U.S. pivotal trial of COPAXONE®(glatiramer acetate injection) for the treatment of relapsing forms of multiple sclerosis (RMS). The extension study initially examined …

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