The U.S. Food and Drug Administration (FDA) has approved Scinopharm Taiwan’s glatiramer acetate injection, a generic of Copaxone, to treat multiple sclerosis (MS). Scinopharm is the first pharmaceutical company in Taiwan to win U.S. approval for glatiramer acetate, marking a significant milestone…
Drug approval
After months of delay, the U.S. Food and Drug Administration (FDA) has rejected Sanofi‘s application seeking approval of tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (MS). While Sanofi announced earlier this month that the decision was likely to be delayed again…
The U.S. Food and Drug Administration (FDA) has given tentative approval to Lupin’s Siponimod tablets, a bioequivalent version of Mayzent (siponimod), to treat people with relapsing forms of multiple sclerosis (MS). According to a company press release, the therapy is indicated for use in adults with clinically isolated syndrome,…
Zydus Lifesciences received final approval from the U.S. Food and Drug Administration (FDA) to market a generic version of Vumerity (diroximel fumarate) for adults with relapsing forms of multiple sclerosis (MS) and other conditions. The drug will be sold as 231 mg delayed-release capsules, produced at Zydus’s…
Note: This story was updated Sept. 23, 2025, to correct the generic name of Aubagio from tolebrutinib to teriflunomide. The U.S. Food and Drug Administration (FDA) has delayed by three months its decision on whether or not to approve Sanofi’s tolebrutinib as a treatment for multiple sclerosis (MS),…
A generic formulation of Zeposia (ozanimod), which won tentative approval for treating multiple sclerosis (MS) from the U.S. Food and Drug Administration (FDA), will be manufactured and supplied by Synthon, based in the Netherlands. Tentative approval means the generic version has met all FDA requirements for…
Immunic Therapeutics will receive a new U.S. patent covering its experimental therapy, vidofludimus calcium, and some related molecules in people with multiple sclerosis (MS). Titled “Treatment of multiple sclerosis comprising DHODH inhibitors,” the patent explicitly covers the use of the molecules in progressive types of MS, including primary…
The United Arab Emirates became the first country to approve tolebrutinib, clearing it to treat adults with nonrelapsing secondary progressive multiple sclerosis (SPMS). Sanofi’s oral BTK inhibitor is also the first approved therapy that directly addresses the chronic inflammation that contributes to disability progression independent of relapses. “The…
The U.S. Food and Drug Administration (FDA) has approved a new generic form of glatiramer acetate injection, a treatment for relapsing forms of multiple sclerosis (MS) that was originally approved under the brand name Copaxone. The generic was developed by Zydus Lifesciences in collaboration with Chemi S.p.A.,…
The U.S. Food and Drug Administration (FDA) has approved a prefilled syringe format for Ani Pharmaceuticals’ purified Cortrophin Gel that’s expected to reduce the number of steps needed for administering the therapy — used in multiple sclerosis (MS) to treat relapses. The approval means that people with conditions…
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Sanofi’s BTK inhibitor candidate tolebrutinib for the treatment of adults with nonrelapsing secondary progressive multiple sclerosis (SPMS). According to Sanofi, tolebrutinib is the first investigational BTK inhibitor with the ability to reach the brain…
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…
Tiziana Life Sciences has received fast track designation from the U.S. Food and Drug Administration (FDA) for its intranasal foralumab to treat nonactive secondary progressive multiple sclerosis (SPMS). The FDA gives fast track status to experimental medicines that have the potential to fill unmet needs to treat serious…
A subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab) received approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with multiple sclerosis (MS). The approval means that people with relapsing forms of MS and those with primary progressive MS (PPMS) will now be…
The European Commission has approved a subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab) to treat adults with multiple sclerosis (MS). The approval makes the new formulation available in the European Union for the same indications as the original intravenous (into-the-vein) formulation, which is available to people with relapsing…
A committee of the European Medicines Agency (EMA) is recommending the approval of a subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab) for people with multiple sclerosis (MS) in the European Union. The Committee for Medicinal Products for Human Use, known as CHMP, specifically recommended that this new formulation…
The U.S. Food and Drug Administration (FDA) has decided not to approve an application seeking clearance of GA Depot — a long-acting formulation of glatiramer acetate — for the treatment of relapsing forms of multiple sclerosis (MS). Importantly, this is not a rejection of the application for the…
The European Commission has approved Tyruko (natalizumab), the first biosimilar of Tysabri, for the treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The approval makes Tyruko available in the European Union for the same indication as its reference medicine. It also marks the first approval…
The U.S. Food and Drug Administration (FDA) has approved Tyruko (natalizumab-sztn) as the first biosimilar of Tysabri to treat adults with relapsing forms of multiple sclerosis (MS). The decision also marks the first approval of any biosimilar for MS in the country, according to the regulatory agency.
The U.S. Food and Drug Administration (FDA) has agreed to review Viatris and Mapi Pharma‘s application seeking approval of GA Depot for the treatment of relapsing forms of multiple sclerosis (MS). The medication is a long-acting formulation of glatiramer acetate, the active ingredient in the approved…
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended that PB006, a biosimilar version of Tysabri (natalizumab), be approved to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS). The recommendation comes about a year after the regulatory agency…
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 new year is bringing a new disease-modifying therapy (DMT) to the multiple sclerosis (MS) arsenal. Shortly after Christmas, the U.S. Food and Drug Administration (FDA) approved Briumvi (ublituximab), which joins a small group of DMTs that aim to halt MS progression by knocking out certain…
The U.S. Food and Drug Administration has approved TG Therapeutics‘ B-cell-depleting therapy ublituximab under the brand name Briumvi for the treatment of adults with relapsing forms of multiple sclerosis (MS), the company announced. The approval covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive…
Biosimilar, or “follow-on,” forms of disease-modifying therapies (DMTs) that have been approved in a highly regulated area can be considered as safe and effective as their reference medications, according to multiple sclerosis (MS) experts. A biosimilar is a medication that’s highly similar to an existing biological medication in…
The U.S. Food and Drug Administration (FDA) has agreed to review an application requesting that Polpharma Biologics‘ natalizumab, a biosimilar of Tysabri, be approved to treat relapsing forms of multiple sclerosis (MS). Its intended U.S. use is for the same indications as the approved name-brand medicine, covering clinically isolated…
The European Medicines Agency (EMA) has agreed to review a request to approve Polpharma Biologics‘ biosimilar natalizumab for the treatment of multiple sclerosis (MS). This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, an approved MS treatment. “The acceptance…
The U.S. Food and Drug Administration (FDA) is extending by three months its review of ublituximab, an experimental anti-CD20 antibody being developed by TG Therapeutics for relapsing forms of multiple sclerosis (MS). The FDA had agreed to review the company’s application requesting ublituximab’s approval late last year, and…
The National Institute for Health and Care Excellence (NICE) has added oral Vumerity (diroximel fumarate), approved to treat relapsing-remitting multiple sclerosis (RRMS) in the U.K., to the list of medications available through the public health program for England. Because the therapy has been recommended through a fast track appraisal process, Vumerity…
Note: An earlier version of this story stated the Scottish Medicines Consortium approved Vumerity for RRMS patients in that country. The consortium decides to add a medicine to Scotland’s National Health Service; the MHRA approves treatments for England, Scotland, and Wales. The Scottish Medicines Consortium has approved adding the…