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FDA Accepts Mitsubishi Tanabe Pharma’s NDA Filing for Edaravone to Treat ALS

Submitted by jcook on Tue, 08/30/2016 - 12:31
Edaravone may be the first ALS treatment approved in U.S. in more than 20 years.

As many as 30,000 Americans are estimated to be affected by ALS and more than 5,600 are diagnosed annually.
FDA Accepts Marathon Pharmaceuticals’ New Drug Applications for Deflazacort for the Treatment of Duchenne Muscular Dystrophy and Grants Priority Review

Submitted by jcook on Wed, 08/10/2016 - 10:01

— FDA approval would allow widespread access for U.S. patients with Duchenne —
— Deflazacort could be among the first FDA-approved treatments for this devastating genetic disorder —
Spinal Muscular Atrophy Drug Successfully Meets Primary Endpoint in Interim Analysis of Phase 3 Study for Infants with SMA

Submitted by kschaaf on Mon, 08/01/2016 - 16:46

MDA funded foundational research and contributed to early-stage development of nusinersen

Aug. 1, 2016

Background:
America’s Fire Fighters Fill the Boot to Support Kids and Adults with Muscular Dystrophy, ALS and Related Diseases

Submitted by kschaaf on Thu, 07/28/2016 - 11:46

Annual Fill the Boot drives heat up this summer to help bring strength, independence and life to those affected
FDA Turns Down Santhera Pharmaceuticals’ Request for Accelerated Approval for Idebenone to Treat DMD

Submitted by jcook on Fri, 07/22/2016 - 10:57

Background: Santhera Pharmaceuticals has been notified by the U.S. Food and Drug Administration (FDA) that the company must include results from its SIDEROS clinical trial at the time that it files a New Drug Application (NDA) for idebenone to treat Duchenne muscular dystrophy (DMD).
MDA and CMTA Partner to Advance Treatments and Care for Charcot-Marie-Tooth Disease

Submitted by jcook on Mon, 07/11/2016 - 14:17

CHICAGO, July 12, 2016 – The Muscular Dystrophy Association (MDA) and the Charcot-Marie-Tooth Association (CMTA) today announced a partnership aimed at advancing Charcot-Marie-Tooth disease (CMT) research, therapy development and clinical care. The partnership also aims to increase awareness and understanding about the disease by improving education for kids and adults affected by CMT, medical professionals and the public.

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Press Releases

FDA Accepts Mitsubishi Tanabe Pharma’s NDA Filing for Edaravone to Treat ALS

FDA Accepts Marathon Pharmaceuticals’ New Drug Applications for Deflazacort for the Treatment of Duchenne Muscular Dystrophy and Grants Priority Review

Spinal Muscular Atrophy Drug Successfully Meets Primary Endpoint in Interim Analysis of Phase 3 Study for Infants with SMA

MDA funded foundational research and contributed to early-stage development of nusinersen

America’s Fire Fighters Fill the Boot to Support Kids and Adults with Muscular Dystrophy, ALS and Related Diseases

FDA Turns Down Santhera Pharmaceuticals’ Request for Accelerated Approval for Idebenone to Treat DMD

MDA and CMTA Partner to Advance Treatments and Care for Charcot-Marie-Tooth Disease

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About Us

Press Releases

FDA Accepts Mitsubishi Tanabe Pharma’s NDA Filing for Edaravone to Treat ALS

FDA Accepts Marathon Pharmaceuticals’ New Drug Applications for Deflazacort for the Treatment of Duchenne Muscular Dystrophy and Grants Priority Review

Spinal Muscular Atrophy Drug Successfully Meets Primary Endpoint in Interim Analysis of Phase 3 Study for Infants with SMA

MDA funded foundational research and contributed to early-stage development of nusinersen

America’s Fire Fighters Fill the Boot to Support Kids and Adults with Muscular Dystrophy, ALS and Related Diseases

FDA Turns Down Santhera Pharmaceuticals’ Request for Accelerated Approval for Idebenone to Treat DMD

MDA and CMTA Partner to Advance Treatments and Care for Charcot-Marie-Tooth Disease

Find MDA in your Community

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in your Community