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Multiple Sclerosis News (Page 5)

Related terms: MS

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...

FDA Approves Lemtrada (alemtuzumab) for Relapsing Forms of Multiple Sclerosis

CAMBRIDGE, Mass., November 14, 2014 --(BUSINESS WIRE) --Genzyme, a Sanofi company, announced today that the U.S. Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for the...

FDA Approves Plegridy (peginterferon beta-1a) for the Treatment of Multiple Sclerosis

CAMBRIDGE, Mass.- August 15, 2014 – Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has approved Plegridy (peginterferon beta-1a), a new treatment for people with relapsing...

Teva Announces U.S. FDA Approval of Three-Times-a-Week Copaxone (glatiramer acetate injection) 40mg/mL

JERUSALEM--(BUSINESS WIRE)--Jan. 28, 2014-- Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental new drug a...

FDA Medwatch Alert: Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection

ISSUE: FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod)....

FDA Approves Tecfidera - a New Treatment for Multiple Sclerosis

March 27, 2013 – The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS). MS is a chronic,...

FDA Approves New Multiple Sclerosis Treatment Aubagio

September 12, 2012 – The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS). ...

FDA Medwatch Alert: Ampyra (dalfampridine): Drug Safety Communication - Seizure Risk for Multiple Sclerosis Patients

ISSUE: FDA is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received...

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prednisone, methylprednisolone, Medrol, prednisolone, valacyclovir, dexamethasone, Tecfidera, Ocrevus, Gilenya, dimethyl fumarate, Aubagio