September 1, 2023 Columns by Ed Tobias The 1st biosimilar OK’d as an MS DMT should save patients money The late August approval of Tyruko (natalizumab-sztn) by the U.S. Food and Drug Administration (FDA) is big news in the multiple sclerosis (MS) world. Tyruko is a biosimilar for Tysabri (natalizumab), and it’s the first biosimilar to gain FDA approval as an MS disease-modifying therapy…
January 19, 2023 News by Lindsey Shapiro, PhD Tascenso ODT, a Gilenya Alternative, Wins New FDA Approval in MS The U.S. Food and Drug Administration has approved Tascenso ODT, a bioequivalent formulation of the multiple sclerosis (MS) therapy Gilenya (fingolimod), at a higher patient dose, according to the pharmaceutical company that will market the treatment in the U.S. The newly approved therapy, which is delivered as…
June 15, 2022 News by Lindsey Shapiro, PhD Ekso’s Wearable Exoskeleton Cleared by FDA for Walking Rehab Use The U.S. Food and Drug Administration has given Ekso Bionics clearance to market its wearable robotic exoskeleton to aid in rehabilitation programs to improve gait and mobility in people with multiple sclerosis (MS). Dubbed EksoNR, the device had been approved by the regulatory agency for stroke and spinal…
March 19, 2021 News by Marisa Wexler, MS Ponvory (ponesimod) Approved for Adults With Relapsing Forms of MS The U.S. Food and Drug Administration (FDA) has approved Ponvory (ponesimod) as an oral treatment for adults with relapsing forms of multiple sclerosis (MS). The approval covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). The treatment is taken as a…
December 15, 2020 News by Marta Figueiredo, PhD FDA Approves Shorter Infusion Time for MS Therapy Ocrevus The U.S. Food and Drug Administration has approved a shorter infusion time of Ocrevus (ocrelizumab) for treating relapsing or primary progressive multiple sclerosis (MS). Infusion refers to the slow delivery of a therapy directly into the bloodstream over a period of time. The decision shortens the twice-yearly infusion…
May 5, 2020 News by Steve Bryson, PhD FDA Approves Bafiertam, Tecfidera Bioequivalent, for Relapsing MS The U.S. Food and Drug Administration (FDA) has given final approval toĀ Banner Life Sciencesā Bafiertam (monomethyl fumarate),Ā a bioequivalent alternative to Biogenās Tecfidera (dimethyl fumarate) to treat people with relapsing…
April 1, 2019 Columns by Ed Tobias MS News that Caught My Eye Last Week: Reaction to SPMS DMT Approval, Ozanimod’s FDA Application, Caregiving Partnerships, a New Preventive Medication? MS Patient Groups React Favorably to Mayzent Approval, But Question Therapyās Price Tag The approval of this medication is very good news. However, as the headline indicates, it comes with a relatively hefty cost. It’s approved for active secondary progressive multiple sclerosis (SPMS), and many of us have SPMS…
July 31, 2017 News by Joana Fernandes, PhD FDA Approves Cognigram Cognitive Assessment Device for Marketing in US The U.S. Food and Drug Administration (FDA) has approved the marketingĀ ofĀ Cognigram, a medical device developed by the cognitive science company CogstateĀ to evaluate a patientās cognitive health. This device may be a…
March 31, 2017 News by Patricia Silva, PhD Diplomat Pharmacy Chosen to Dispense Ocrevus to MS Patients Across US Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., has been selected to dispenseĀ Ocrevus (ocrelizumab), a limited-distribution drug,Ā to people withĀ relapsingĀ andĀ primary progressive multiple sclerosis. Ocrevus was approved by the U.S. Food and Drug Administration on March 28, becoming the first therapy approved for both RMS and…