FDA Approves Gilenya® for Pediatric MS

On May 11, 2018, Novartis announced that Gilenya® (fingolimod) was approved by the United States Food and Drug Administration (FDA) for the treatment of children and adolescents, ages 10 through 17, with relapsing multiple sclerosis (MS). This is the first disease-modifying therapy (DMT) to be approved for this form of the disease in this age […]

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FDA Helping with Zinbryta® Withdrawal

As a follow-up to MSAA’s online article, “Zinbryta® Withdrawn from Marketplace,” MSAA is alerting individuals taking Zinbryta® (daclizumab) to additional information on the withdrawal. On March 14, 2018, the United States Food and Drug Administration (FDA) issued a press release to assist with the withdrawal of Zinbryta from the market in the United States. They […]

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Zinbryta® Withdrawn from Marketplace

On March 2, 2018, Biogen and AbbVie announced the voluntary withdrawal of their MS medication, Zinbryta® (daclizumab), due to new safety concerns. Eight cases of inflammatory encephalitis and meningoencephalitis – both forms of brain inflammation – have been reported in two European countries. According to Reuters, seven cases of these serious brain disorders occurred in […]

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MSAA Draws Attention to Multiple Sclerosis Progression during MS Awareness Month

The organization will host a series of activities and events focused on providing education and raising awareness about multiple sclerosis during the month of March March is officially recognized as MS Awareness Month, and the Multiple Sclerosis Association of America (MSAA) is focusing their 2018 MS Awareness Month campaign on Understanding MS progression, with specific […]

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FDA Approves Three-Times Weekly Dose of Glatopa®

Sandoz, a Novartis division, announced today that the United States Food and Drug Administration (FDA) approved Glatopa® (glatiramer acetate injection) at a three-times weekly 40-mg dose. This generic version of Copaxone®, a disease-modifying therapy (DMT) approved for the treatment of relapsing forms of multiple sclerosis (MS), was initially approved at a 20-mg daily dose. Both […]

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Bloomberg Senior Executive Editor Among Honorees at National Annual Benefit

John McCorry, Senior Executive Editor for the Americas at Bloomberg News; Dorothea Pfohl, Founding Member of IOMSN; and the Knights of Columbus Santa Maria Council #1443 will be recognized by MSAA The Multiple Sclerosis Association of America (MSAA) is proud to announce their distinguished honorees for the 2018 Improving Lives Benefit scheduled for Thursday, March […]

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FDA Grants Gilenya® Breakthrough Therapy Designation for Pediatric MS

On December 18, 2017, Novartis announced that Gilenya® (fingolimod) was granted breakthrough therapy designation by the United States Food and Drug Administration (FDA) for the treatment of children and adolescents ages 10 years or older with relapsing multiple sclerosis (MS). Known as “pediatric MS,” nearly all (98 percent) of those diagnosed experience the relapsing form […]

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