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Multiple Sclerosis News (Page 4)
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FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis
South San Francisco, CA – December 14, 2020 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a...
FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis
Basel, August 20, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the trea...
FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of...
FDA Approves Vumerity (diroximel fumarate) for Multiple Sclerosis
CAMBRIDGE, Mass. and DUBLIN, Ireland, Oct. 30, 2019 (GLOBE NEWSWIRE) – Biogen Inc. (Nasdaq: BIIB) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA)...
FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis
March 29, 2019 – The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting...
FDA Approves Mayzent (siponimod) for Secondary Progressive Multiple Sclerosis
Basel, March 27, 2019 - Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent (siponimod) for the treatment of adults with relapsing forms of multiple...
FDA Medwatch Alert: FDA Warns About Rare But Serious Risks of Stroke and Blood Vessel Wall Tears with Multiple Sclerosis Drug Lemtrada (alemtuzumab)
The U.S. Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis...
FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine
ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being...
FDA Expands Approval of Gilenya (fingolimod) to Treat Multiple Sclerosis in Pediatric Patients
May 11, 2018 – The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the...
FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis
South San Francisco, CA – March 28, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Ocrevus...
FDA Approves Zinbryta (daclizumab) to Treat Multiple Sclerosis
May 27, 2016 – The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting...
FDA Approves Betaconnect Electronic Autoinjector for the Treatment of Relapsing-Remitting Multiple Sclerosis
WHIPPANY, N.J., Sept. 25, 2015 /PRNewswire/ – Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) approved Betaconnect, the first and only electronic autoinjector in...
FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection
ISSUE: FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple...
FDA Approves Glatopa (glatiramer acetate) as the First Generic Competitor to Copaxone
Holzkirchen, Germany, April 16, 2015 - Sandoz, a Novartis company, today announced the US approval of Glatopa, the first generic version of Teva's Copaxone (glatiramer acetate injection) 20 mg/ml...
FDA Medwatch Alert: Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported
ISSUE: FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal...
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