The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to privosegtor, an experimental treatment from Oculis that aims to protect the vision of people experiencing acute optic neuritis. This condition, which involves inflammation of the optic nerve, is a common and often debilitating symptom of…
Drug approval
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…
The National Institute for Health and Care Excellence (NICE) in England is recommending natalizumab — sold as Tysabri and Tyruko — as an option for certain people with hard-to-control multiple sclerosis (MS). NICE is responsible for deciding which medicines will be covered by the National Health Service…
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…
Following negative Phase 3 trial results, Sanofi announced that it will not be pursuing approval of its experimental therapy tolebrutinib for primary progressive multiple sclerosis (PPMS). Meanwhile, a decision from the U.S. Food and Drug Administration (FDA) on tolebrutinib’s use in nonrelapsing secondary progressive MS (SPMS) is likely…
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,…
Lynk Pharmaceuticals has received the green light from the U.S. Food and Drug Administration (FDA) to begin clinical trials of its investigational oral therapy LNK01006, which is being developed for multiple sclerosis (MS) and other neuroinflammatory diseases. “We look forward to advancing this promising molecule into human clinical…
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…
The U.S. Food and Drug Administration (FDA) granted fast track designation to EG110A, EG 427‘s DNA-based therapy to treat neurogenic detrusor overactivity (NDO) — a bladder disorder that can arise from spinal cord injury or neurodegenerative conditions such as multiple sclerosis (MS). The FDA gives fast track status to experimental…
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),…
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…
Three biosimilar drugs — approved versions of brand-name therapies that have no clinically meaningful differences compared with their reference products — including one for multiple sclerosis (MS), will soon be available in the Middle East and North Africa (MENA) region under a new partnership between two pharmaceutical companies.
The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Hope Biosciences‘ adipose-derived mesenchymal stem cells (HB-adMSCs) to treat relapsing-remitting multiple sclerosis (RRMS). RMAT status is given to therapies with compelling proof that they may substantially improve patient outcomes compared with existing…
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…
Quantum Biopharma filed a U.K. innovation passport application to streamline the development and review of Lucid-21-302 (Lucid-MS), a therapy designed to promote myelin repair in people with multiple sclerosis (MS). The submission, made via Quantum’s Australian subsidiary, Huge Biopharma Australia, marks the first step to entering the U.K.’s Innovative…
Alvotech, a developer of biosimilar medicines, is expanding its partnership with Advanz Pharma to commercialize three new products in Europe — one of them a biosimilar of Kesimpta (ofatumumab), a drug used for treating multiple sclerosis (MS). Biosimilars are therapies that have no clinically meaningful differences…
Quantum Biopharma intends to ask the U.S. Food and Drug Administration (FDA) this year for permission to start a Phase 2 clinical trial testing Lucid-21-302, its novel therapy for promoting myelin repair, in people with multiple sclerosis (MS). The company announced that it has completed dosing in a…
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.,…
Note: This story was updated April 4, 2025, to clarify the specific disability measures and that tolebrutinib is believed to target smoldering neuroinflammation. The U.S. Food and Drug Administration (FDA) has granted priority review to an application from Sanofi seeking the approval of its BTK inhibitor…
Myrobalan Therapeutics has been awarded a grant of more than $850,000 from the National Multiple Sclerosis Society to advance its new oral candidate MRO-002 for treating progressive forms of multiple sclerosis (MS). The funding was made through the society’s Fast Forward program, which seeks to bridge the…
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 cleared an extended version of Neurophet Aqua, an MRI analysis software that uses artificial intelligence (AI) to measure disease-related changes in brain scans. Earlier clearance enabled Neurophet‘s software to analyze brain atrophy using T1-weighed MRI scans in people with neurodegenerative conditions.
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…
A potential treatment of relapsing-remitting multiple sclerosis (RRMS), arsenic trioxide (ATO) has been patented in the European Union based on findings in preclinical studies. Notice of an intent to grant patent EP18722530, titled “Method for treating relapsing-remitting multiple sclerosis using arsenic trioxide,” was given by the European Patent…
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 U.S Food and Drug Administration (FDA) authorized an investigational new drug application from Synaptogenix, clearing the company to launch a clinical trial to test whether its lead candidate bryostatin-1 can prevent cognitive decline in people with multiple sclerosis (MS). The open-label, Phase 1 clinical trial (NCT06190912),…
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…
Siemens Healthineers has received the CE mark in Europe for a lab-based blood test that measures the levels of neurofilament light chain, known as NfL — a protein that gets released into the bloodstream upon damage to nerve cells — in adults with relapsing forms of multiple sclerosis…