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Multiple Sclerosis News (Page 5)
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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...
FDA Medwatch Alert: Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose
[UPDATED 05/14/2012] FDA has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional ...
Novartis Gains FDA Approval For Gilenya, A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly Reduce Relapses And Delay Disability Progression
Basel, September 22, 2010 - Today, Novartis announced that the US Food and Drug Administration (FDA) approved the oral multiple sclerosis (MS) treatment Gilenya (fingolimod) 0.5 mg daily, a...
FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated...
US FDA Approves Extavia - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with This Devastating Disease
Basel, August 17, 2009 - The US Food and Drug Administration (FDA) has approved Extavia (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis...
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prednisone, methylprednisolone, Medrol, prednisolone, valacyclovir, dexamethasone, Tecfidera, Ocrevus, Gilenya, dimethyl fumarate, Aubagio