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New Phase 1b data support the safety and effectiveness of salanersen over one year in children with SMA who had the potential for improvement due to suboptimal clinical status with prior gene...
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Findings from DEVOTE support clinical benefits of the high-dose regimen of nusinersen (50 mg and 28 mg) in both treatment-naïve individuals and those previously treated with 12 mg nusinersenThe...
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Approval is supported by data from the DEVOTE study which showed the benefit of the SPINRAZA 50 mg and 28 mg regimen in both treatment-naïve and previously-treated nusinersen patients with SMA1Biogen...
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New York, Nov. 24, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) today called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve),...
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New York, Nov. 20, 2025 (GLOBE NEWSWIRE) -- This NFL season, during games in Weeks 12 and 13, hundreds of NFL players will step onto the field in custom-designed cleats as part of the 10th annual My...
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Positive CHMP opinion is based on data from the DEVOTE study which evaluated the high dose regimen of nusinersen in treatment-naive participants and those transitioning from the currently approved...
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New York, Oct. 20, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) today kicked off its largest annual MDA Holiday Retail Campaign, spanning thousands of retail locations...
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New analyses from DEVOTE Part C further characterize the improvements in motor function in participants with SMA who transitioned to the investigational higher dose regimen of nusinersen from 12 mg...
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New York, Feb. 27, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) announced today that Robert Califf, MD, MAAC, former Commissioner of the U.S. Food and Drug Administration and...
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New York, Feb. 12, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) today celebrates the decision by the US Food and Drug Administration (FDA) to grant approval of a risdiplam...