approval

April 1, 2019April 18, 2019

FDA Approves EMD Serono’s Mavenclad as Treatment for RRMS and Active SPMS

News

The U.S. Food and Drug Administration has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) and active secondary ... Read more

March 27, 2019March 29, 2019

FDA Approves Novartis’ Mayzent for Relapsing Forms of Multiple Sclerosis, Including Active SPMS

News

The U.S. Food and Drug Administration (FDA) has approved Novartis’ Mayzent (siponimod) oral tablets for adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting ... Read more

March 12, 2019March 12, 2019

Celgene Seeks Approval in European Union for Ozanimod to Treat Adult RRMS

News

An application has been submitted for the use of ozanimod to treat adult patients with relapsing-remitting multiple sclerosis (RRMS) within the European Union, according to Celgene, the developer of ozanimod. The marketing ... Read more

November 30, 2018December 13, 2018

Gilenya Now Approved in Europe to Treat Children, Adolescents with RRMS

News

Gilenya (fingolimod) was approved by the European Commission as a treatment for children and adolescents, ages 10 to 17, with relapsing-remitting multiple sclerosis (RRMS), Novartis announced. The therapy is ... Read more

March 1, 2018March 8, 2018

Argentina Approves Mavenclad for Active Relapsing MS

News

Argentina has become the first country in Latin America to approve Mavenclad (cladribine) as a treatment for adults with highly active relapsing multiple sclerosis. The Argentinian Administration of Medicines, Food and ... Read more

February 16, 2018May 21, 2018

Health Canada Approves Ocrevus to Treat Early Stage PPMS Patients with Active Disease

News, Ocrevus

Primary progressive multiple sclerosis (PPMS) patients in Canada in the earlier stages of this disease can now be treated with Ocrevus (ocrelizumab), following Health Canada‘s decision to approve its use ... Read more

February 15, 2018February 15, 2018

FDA Approves Dose of MS Therapy Glatopa That Is Twice as Large as Current One

News

The U.S. Food and Drug Administration has approved a new dose of Sandoz’s multiple sclerosis therapy Glatopa (glatiramer acetate injection) that is twice as large as the currently authorized one. Regulators’ approval ... Read more

January 15, 2018May 21, 2018

European Commission Approves Ocrevus to Treat RRMS, PPMS Throughout EU

News, Ocrevus

The European Commission has approved Roche’s Ocrevus (ocrelizumab) for both relapsing-remitting multiple sclerosis (RRMS) and primary-progressive multiple sclerosis (PPMS) across the 28-member European Union. The commission’s move —  nearly 10 ... Read more

December 11, 2017December 14, 2017

Australia Approves Shorter Mavenclad Treatment Regimen for Relapsing-Remitting MS

News

Australia has approved a shorter treatment regimen of Merck’s Mavenclad for relapsing-remitting multiple sclerosis. The Therapeutic Goods Administration authorized 20-day courses of the cladribine tablet form of the medication once a year for ... Read more

December 6, 2017December 7, 2017

Health Canada Approves Merck’s Mavenclad to Treat RRMS

News

Canadians with relapsing-remitting multiple sclerosis can now receive Merck’s Mavenclad, now that Health Canada has approved Mavenclad as a therapy to reduce the frequency of MS exacerbations and delay disease progression. Merck expects ... Read more

November 14, 2017May 21, 2018

Europe’s CHMP Urges Approval of Ocrevus in EU to Treat Relapsing, Primary Progressive MS

News, Ocrevus

Europeans with relapsing multiple sclerosis (MS) and early primary progressive MS are one step closer to accessing Ocrevus, now that the European Medicines Agency has urged the European Union to approve the ... Read more

October 9, 2017October 10, 2017

In Blow to Teva, EU Approves Synthon’s Generic Version of Copaxone to Treat RRMS

News

Synthon’s prefilled syringe with 40 mg/ml of glatiramer acetate — the generic version of Teva Pharmaceutical’s Copaxone 40 mg — has received regulatory clearance in all 28 member states ... Read more

September 29, 2017May 21, 2018

Switzerland First in Europe to Approve Ocrevus for Relapsing and Primary Progressive MS

News, Ocrevus

Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in ... Read more

August 29, 2017August 30, 2017

Merck’s Mavenclad, an Oral Therapy for Relapsing MS, Approved in European Union

News

The European Commission has approved Merck KGaA’s Mavenclad (cladribine tablets) to treat highly active relapsing forms of multiple sclerosis (MS). The Aug. 25 decision in Brussels marks the first approval of a ... Read more

August 22, 2017August 23, 2017

Mavenclad Improves Relapsing MS Patients’ Quality of Life, Independent U.K. Study Finds

News

Merck’s Mavenclad tablets significantly improve quality of life among relapsing multiple sclerosis patients while reducing the number of relapses, according to new analyses of previously unpublished data from clinical ... Read more

July 18, 2017May 21, 2018

Australian Authorities Approve Ocrevus Following U.S. Endorsement of Breakthrough MS Therapy

News, Ocrevus

Australia has become the first country to approve Genentech’s Ocrevus for relapsing and primary progressive multiple sclerosis treatment since the therapy’s initial approval by the U.S. Food and Drug ... Read more

June 27, 2017June 29, 2017

Cladribine Tablets Are Only a Step Away from European Union Approval for Relapsing Multiple Sclerosis

News

Merck’s cladribine tablets are now just one step away from obtaining European Union approval as a relapsing multiple sclerosis treatment. The European Medicines Agency’s Committee for Medicinal Products for Human ... Read more

May 25, 2017May 25, 2017

Fampyra Granted Standard Approval in Europe as Trial Results Support Effectiveness

News

Fampyra (prolonged-release fampridine tablets) — sold in the U.S. as Ampyra (dalfampridine) — has now been granted standard marketing authorization in Europe. The approval was based on the results ... Read more

April 6, 2017May 21, 2018

‘Adequate and Rapid Delivery’ of Ocrevus Expected, Says Genentech Director in Interview

News, Ocrevus

Ocrevus (ocrelizumab), now approved for both relapsing and primary progressive multiple sclerosis (MS), is expected to become available in the coming week. While patients and neurologists are waiting, Multiple Sclerosis ... Read more

April 5, 2017May 21, 2018

UCSF Neurologist Played Key Role in MS Research Turning to B-Cells, Essential Step to Ocrevus

News, Ocrevus

Dr. Stephen Hauser, chair of the neurology department at the University of California San Francisco, was instrumental in the early research and later clinical trials that ultimately led to Ocrevus (ocrelizumab), ... Read more

April 4, 2017May 21, 2018

Transcript of Interview with Dr. Robert Lisak, a Neurologist and MS Expert, About Ocrevus

News, Ocrevus

Here is a transcript of the Multiple Sclerosis News Today interview about Ocrevus (ocrelizumab) with Dr. Robert Lisak of the Consortium of Multiple Sclerosis Centers (CMSC). Lisak, a professor ... Read more

April 4, 2017May 21, 2018

Ocrevus Holds Promise, But Needs to Prove Itself in ‘Long Term,’ Says Dr. Robert Lisak with CMSC

News, Ocrevus

Interest in  Ocrevus (ocrelizumab), the first FDA-approved treatment for both relapsing and primary progressive multiple sclerosis, is running high among patients and the organization representing them — as, arguably, are expectations ... Read more

March 30, 2017May 21, 2018

Hope, But No Cheers Yet, Voiced by MS Groups in Europe and Canada Waiting on Own Ocrevus Decision

News, Ocrevus

American patient groups and neurologists have clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. ... Read more

March 29, 2017May 21, 2018

Excitement to Cautious Optimism — Reactions to Approval of Ocrevus

News, Ocrevus

The historic approval of Ocrevus (ocrelizumab), the first-ever treatment for primary progressive multiple sclerosis (MS), set off ripples in the relatively calm waters of MS news reporting. The drug, which ... Read more

March 16, 2017March 16, 2017

After Long Wait, Zinbryta Gains Approval in Areas of the UK

Columns, What's Important Now -- An MS Column by Ian Franks

News that daclizumab, brand name Zinbryta, has been given the go-ahead to be available through the U.K.’s National Health Service (NHS) for treating relapsing MS, at least in part of ... Read more

October 4, 2016October 12, 2016

NICE Planning to Reject MS Treatment, Zinbryta, in England and Wales

News

The National Institute for Health and Care Excellence (NICE), the health authority for England and Wales, has decided not to recommend Zinbryta (daclizumab) be made available to multiple sclerosis (MS) patients through the country’s ... Read more

May 31, 2016May 31, 2016

Multiple Sclerosis treatment Zinbryta (Daclizumab) Approved by FDA

News

Zinbryta (daclizumab) was approved May 27 for the treatment of adults with relapsing multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) cleared Biogen’s new long-acting injection as ... Read more