FDA

8 More SPMS Patients Cleared for Foralumab Nasal Spray Treatment

Based on findings from the first two secondary progressive multiple sclerosis (SPMS) patients givenĀ foralumab nasal spray, an experimental therapy, the U.S. Food and Drug Administration (FDA) has approved starting treatment in up to eight other patients under a special access program. Those enrolled in this intermediate-size expanded access…

2nd Patient to Get Foralumab Nasal Spray After Promising First Data

Following promising data from the first participant in a special access program that’s testingĀ foralumabĀ nasal spray forĀ secondary progressive multiple sclerosis (SPMS), a second patient has been enrolled in the ongoing evaluation. The first patient in the study, by Tiziana Life Sciences, the nasal spray’s developer, was halfway through…

FDA Approves Lyvispah, Granular Form of Baclofen, to Treat Spasticity

The U.S. Food and Drug Administration (FDA) has approved Lyvispah, a dissolvable granular formulation of baclofen, to treat spasticityĀ in people withĀ multiple sclerosis (MS). The strawberry-flavored formulation, developed byĀ Saol Therapeutics, is particularly suitable to ease flexor spasticity, the involuntary bending of the knees and hips toward the…

Ublituximab, Potential Relapsing MS Therapy, Up for FDA Approval

TG TherapeuticsĀ  has applied to the U.S. Food and Drug Administration (FDA) for approval ofĀ ublituximab, the companyā€™s investigational anti-CD20 monoclonal antibody therapy for relapsing forms of multiple sclerosis (RMS). Its application was based on data from the ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) Phase…

FDA to Review ANI’s Request for Cortrophin Gel Use

The U.S. Food and Drug Administration (FDA) has agreed to review ANI Pharmaceuticalsā€™ supplemental new drug application for the approval of Cortrophin Gel to treat people with multiple sclerosis (MS) and other chronic inflammatory conditions, including rheumatoid arthritis. Purified Cortrophin Gel (repository corticotropin injection USP) is a purified…

FDA Rejects Expansion of Aubagio for Pediatric MS

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…

FDA Rejects Under-the-skin Tysabri for Relapsing MS

The U.S. Food and Drug Administration (FDA) has rejected Biogen‘s request for approval of under-the-skin administration of TysabriĀ (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). “This response from the FDA does not affect the intravenous administration of Tysabri, a well-established high-efficacy treatment with a…

FDA Approves Plegridy as Intramuscular Injection for Relapsing MS

The U.S. Food and Drug Administration (FDA) has approved an intramuscular injectionĀ formulation of Plegridy (peginterferon beta-1a) to treat people with relapsing forms of multiple sclerosis (MS). This formulation, for injection directly into muscle, is what is typically used to deliver the flu shot. According to Biogen, Plegridy’s…

Helius Provides More Information to FDA About PoNS Device

Helius Medical Technologies has submitted its response to the U.S. Food and Drug Administration (FDA)’s request for more information about the company’s application for de novoĀ classification and clearance of its portable neuromodulation stimulator (PoNS) device to help treat walking difficulties in people…

FDA Approves Lupin’s Generic Form of Tecfidera for MS Treatment

Lupin‘s generic equivalent ofĀ Tecfidera has been approved by the U.S. Food and Drug Administration (FDA) for the treatment ofĀ multiple sclerosis (MS), the company announced in a press release. The therapy ā€” dimethyl fumarate delayed-release capsules ā€” is indicated for use in people withĀ clinically…

Is the FDA Changing Course on Amalgam Dental Fillings and MS?

For years, some people have warned of a possible connection between multiple sclerosis (MS) and the amalgam fillings many of us have in our teeth. The concern has been that these fillings contain mercury, which can be toxic, especially if they are removed. In large part, these concerns have…

FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS

The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Kesimpta (ofatumumab) as a self-administered treatment for adults with relapsing forms of multiple sclerosis (MS), meaning those withĀ clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…

Mylan Launching Tecfidera Generic in US

Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS). The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid ā€”…