FDA

Helius Medical Technologies has filed an application with the U.S. Food and Drug Administration (FDA) asking for de novo classification and clearance of its portable neuromodulation stimulator (PoNS) device for the treatment of walking deficits in multiple…

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.

Osmotica Pharmaceuticals has submitted an amended new drug application (NDA) to the U.S. Food and Drug Administration (FDA) requesting the approval of arbaclofen extended release (ER) tablets for the treatment of spasticity in people with multiple sclerosis (MS). Arbaclofen ER (brand name…

The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘ ofatumumab, a possible self-administered injection therapy for relapsing multiple sclerosis (MS), the company announced. Originally expected in June, the FDA decision is now expected in September. “Novartis will continue to work with the FDA to…

Zeposia (ozanimod), a newly approved oral capsule treatment for relapsing forms of multiple sclerosis (MS), is now commercially available in the United States, its manufacturer, Bristol Myers Squibb, announced. “We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing]…

The U.S. Food and Drug Administration (FDA) approved adding new safety data on pregnancy and breastfeeding to the U.S. label for Rebif (interferon beta-1a), a disease-modifying treatment for relapsing forms of multiple sclerosis (MS). The label update draws on findings from a large population-based study, together with…

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Helius Medical Technologies’ portable neuromodulation stimulator (PoNS) for the treatment of walking impairments in multiple sclerosis (MS) patients. The device, which is meant to be used…

MMJ International Holdings announced that it has been given clearance to ship its cannabis-based products to the U.S. for use in future clinical trials of potential cannabis-based treatment for multiple sclerosis (MS) and Huntington’s disease. The process was facilitated by the U.S. Drug Enforcement Agency (DEA), which worked alongside…

A portable device that can quickly measure electrical activity in the brain and relay it to doctors via a smartphone app, called the Nurochek system, has been cleared by the United States Food and Drug Administration (FDA) for use as a medical device. Its developer, Headsafe, plans to it…

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to combinations of VTS-Aspirin plus fumarate therapy using Vumerity (diroximel fumarate) or Bafiertam (monomethyl fumarate) for easing flush in patients with relapsing-remitting multiple sclerosis (RRMS). In the U.S., orphan drug designation is given to…

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted applications from Genentech to shorten the infusion time for Ocrevus, an approved treatment for multiple sclerosis. If approved, the time to administer Ocrevus will be shortened to a two-hour session, instead…

Plegridy (peginterferon beta-1a) and Avonex (interferon beta-1a), both by Biogen, may be used — if necessary — by women with relapsing multiple sclerosis who are pregnant or breastfeeding, the U.S. Food and Drug Administration (FDA) announced in updating prescribing information for these MS treatments. Due to the limited…

ANI Pharmaceuticals is asking the U.S. Food and Drug Administration (FDA) for the right to reintroduce in the U.S. market its Cortrophin Gel (repository corticotropin injection, 80 U/ml) to treat acute exacerbations in multiple sclerosis (MS) and other diseases. Currently, the only repository corticotropin injection available in…

The U.S. Food and Drug Administration (FDA) has approved Zeposia (ozanimod) oral capsules to treat adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS),  active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). Due to the COVID-19 pandemic, however, when it will arrive in clinics…

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the investigational new drug (IND) application to assess IMS001 in the treatment of multiple sclerosis (MS), ImStem Biotechnology announced. The company plans to start a Phase 1 study in the U.S. this…

Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) asking for ponesimod to be approved as an oral treatment for adults with relapsing multiple sclerosis (MS). Ponesimod, formerly ACT-128800, is an experimental treatment that targets the protein sphingosine-1-phosphate…

Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, an investigational B-cell therapy for the treatment of relapsing forms of multiple sclerosis (MS) in adults. Novartis’ applications for ofatumumab — which has the…

  The U.S. Food and Drug Administration (FDA) has granted approval to Flowonix Medical’s Prometra II Programmable Pump System for use with intrathecal baclofen for the treatment of spasticity across numerous conditions, including multiple sclerosis. Intrathecal baclofen — sold as Gablofen by Piramal, Lioresal by…

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for QyScore, a cloud-based imaging software for the automated quantification of key magnetic resonance imaging (MRI) markers of central nervous system (CNS) disease. MRI is an important tool for diagnosing multiple sclerosis and other CNS disorders. By…

The U.S. Food and Drug Administration (FDA) has agreed to allow Myeliviz, an imaging agent of myelin — the protective layer that covers nerve fibers and is damaged in multiple sclerosis (MS) — to be evaluated in a clinical trial with healthy volunteers. Myeliviz, created by Case Western Reserve University researchers, has the potential…

Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing — facial redness, itching or rash — in patients with relapsing-remitting multiple sclerosis (RRMS). Flushing is a common side effect of an oral MS therapy called…

Gabapentinoids — a class of therapies sometimes used off-label to help control pain in people with multiple sclerosis (MS) — can increase the risk of serious breathing problems, particularly for those who have risk factors like poorer lung function or use opioid pain medicines, according to a warning…

The U.S. Food and Drug Administration (FDA) approved three generic versions of Gilenya (fingolimod) for the treatment of adults with relapsing forms of multiple sclerosis (MS). A generic is a nearly identical, lower-priced version of an original brand medication. The three generic applications approved Thursday by the…

MMJ International Holdings announced that it has entered into an agreement for the production of its proprietary cannabis-based gel capsule — a product mix of tetrahydrocannabinol (THC) and cannabidiol (CBD) — in compliance with guidelines set by the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).

The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…

MMJ International Holdings, a pharmaceutical company whose focus is plant-derived cannabis products for therapeutic purposes, has requested permission to ship tetrahydrocannabinol (THC) and cannabidiol (CBD) from Canada to the U.S. to be used in upcoming clinical trials for people with multiple sclerosis (MS) and Huntington’s disease. MMJ-001…

A new study demonstrates that intracellular sigma peptide (ISP) can promote remyelination in a mouse model of multiple sclerosis (MS). Importantly, this study was independent of NervGen, a pharmaceutical company that is developing an ISP-like compound — NVG-291 — for the treatment of nerve injury and MS. The study,…

Last night in bed, my calf muscles started cramping. Again. Usually, it’s just my left leg, but last night it was both. The pain wouldn’t ease with my usual stretching routine so I reached for my little bottle of cannabidiol (CBD) oil. I’ve been experimenting with CBD oil on and…

The U.S. Food and Drug Administration (FDA) has approved the use of Botox (onabotulinumtoxinA), marketed by Allergan, for the treatment of children ages 2 to 17 with upper limb muscle stiffness or spasticity, a common symptom in children with…

FDA and EMA to Review Ozanimod as Possible Oral Therapy for Relapsing MS Another disease-modifying therapy (DMT) is a step closer to gaining approval for use both in the U.S. and in Europe. And that’s good news. The discouraging news, however, is that once again, the approval is being…