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…
Priority review
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),…
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…
Ocrevus (ocrelizumab) appears to be safe and effective for children and adolescents with multiple sclerosis (MS), according to real-world data from Kuwait. After about 15 months of treatment, more than 90% of patients with pediatric-onset MS (POMS) remained free of relapses, and most also showed no new…
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…
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…
Treatment with rituximab, an approved CD20 inhibitor that’s sometimes used off-label for multiple sclerosis (MS), was found to adequately control the neurodegenerative disease in patients diagnosed during childhood or adolescence, a new study showed. The therapy, given by infusion into the bloodstream, was generally safe and significantly reduced…
The U.S. Food and Drug Administration (FDA) has granted fast track status to KYV-101, Kyverna Therapeutics’ cell-based therapy candidate for people with progressive forms of multiple sclerosis (MS) that are treatment-resistant. The FDA designation is intended to accelerate the development of therapies that aim to address unmet medical…
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 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 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…
Mapi Pharma announced that it has been granted a U.S. patent covering the use of GA Depot, a potential long-acting formulation of glatiramer acetate, in people with progressive forms of multiple sclerosis (MS). The U.S. Patent and Trademark Office patent, No. 11,167,003, is titled, “…
The Scottish Medicines Consortium (SMC) has recommended that Ponvory (ponesimod) be offered through the National Health Service (NHS) Scotland to people with active, relapsing forms of multiple sclerosis (MS). The decision means that the oral therapy will be available at low or no cost to patients with clinically isolated syndrome (CIS),…
The U.S. Patent and Trademark Office will grant Medsenic a patent covering the use of Arscimed, its investigational formulation of arsenic trioxide, for the treatment of relapsing-remitting multiple sclerosis (RRMS). Once issued, the patent will protect Arscimed’s use for this indication until 2037. This will add to the already…
The U.S. Food and Drug Administration (FDA) has rejected an application requesting the expansion of Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis (MS). “The FDA deemed the data submitted were not sufficient to obtain approval of…
Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people with relapsing multiple sclerosis (MS) — clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decision came through a priority review of clinical trial data for Tecfidera,…
The European Commission (EC) has approved a new, intramuscular formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing-remitting multiple sclerosis (RRMS). This new mode of administration — in which Plegridy is directly injected into the muscle, rather than under the skin (subcutaneously) — does…
Eligible people with relapsing-remitting multiple sclerosis (RRMS) now have access to Mavenclad (cladribine) through seven provincial public drug plans in Canada, including the Régie de l’assurance maladie du Québec (RAMQ) and the Ontario Drug Benefit Exceptional Access Program. The oral treatment now is available through public drug programs…
Mayzent (siponimod) has become the first oral medication to be approved for people with active secondary progressive multiple sclerosis (SPMS) in England and Wales. Following this decision by England’s National Institute for Health and Care Excellence (NICE) — which reversed its opinion announced in June — the…
The U.S. Food and Drug Administration (FDA) has agreed to review  Osmotica Pharmaceuticals‘ amended request for the approval of arbaclofen extended release (ER) tablets to treat spasticity in people with multiple sclerosis (MS), the company announced.
After first rejecting it due to cost-effectiveness concerns, the National Institute for Health and Care Excellence (NICE) has now approved the use of Ocrevus (ocrelizumab) for people in the U.K. with early, inflammatory primary progressive multiple sclerosis (PPMS). This means that PPMS patients living in the…
Novartis is seeking U.S. and European approval of its investigational oral agent siponimod to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…
The U.S. Food and Drug Administration has given fingolimod a Breakthrough Therapy designation as a treatment for children 10 years and older and adolescents with relapsing multiple sclerosis. Novartis is marketing it in the United States under the brand name Gilenya for adults with relapsing MS. It has yet to approved…
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…
Australia has granted a patent to RegeneRx Biopharmaceuticals for an active ingredient in a therapy that could benefit multiple sclerosis (MS) patients. The patent is for Thymosin beta 4 (Tβ4), the driving force in the company’s RGN-352 treatment. RGN-352 promotes myelination, or the production of protective myelin sheaths for damaged neurons and other nerve…
Active Biotech acknowledged in an update on laquinimod, the oral small molecule being developed by Teva Pharmaceutical Industries to treat multiple sclerosis (MS) and Huntington’s disease (HD), that the U.S. Food and Drug Administration (FDA) has rescinded the special protocol assessment given to a Phase 3 study of the treatment in…
Sanofi Genzyme announced that the Government of Ontario has added Lemtrada (alemtuzumab) to the province’s Exceptional Access Program (EAP), opening coverage to the treatment for eligible patients with relapsing-remitting multiple sclerosis (RRMS). The program facilitates patient access to drugs not funded on the Ontario Drug Benefit (ODB) Formulary, or those…