FDA approval

The U.S. Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq), a subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab), for treating adults with multiple sclerosis (MS). The approval covers all the same indications as the original medication, including relapsing forms of MS — namely…

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…

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…

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…

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…

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…

The U.S. Food and Drug Administration (FDA) has given final approval to Banner Life Sciences’ Bafiertam (monomethyl fumarate), a bioequivalent alternative to Biogen’s Tecfidera (dimethyl fumarate) to treat people with relapsing…

MS Patient Groups React Favorably to Mayzent Approval, But Question Therapy’s 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…

The U.S. Food and Drug Administration (FDA) has approved the marketing of Cognigram, a medical device developed by the cognitive science company Cogstate to evaluate a patient’s cognitive health. This device may be a…

Diplomat Pharmacy, the largest independent specialty pharmacy in the U.S., has been selected to dispense Ocrevus (ocrelizumab), a limited-distribution drug, to people with relapsing  and 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…