FDA Approves New Tablet Form of Evrysdi for Treatment of Spinal Muscular Atrophy
The Muscular Dystrophy Association celebrates this new more accessible treatment option for people living with SMA. MDA - New ...
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Spinraza treatment won’t lead to kidney dysfunction, per study
Spinraza treatment does not lead to significant kidney dysfunction in SMA patients with types 1 and 2, a safety and efficacy ...
What To Expect From Alzheimer's Drugmaker Biogen's Q4 Earnings On Wednesday?
Biotech giant Biogen Inc (NASDAQ:BIIB) is scheduled to report fourth-quarter earnings on 12 February. The Wall Street ...
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COVID-19 made life with SMA more difficult, parents and doctors say
In surveys, parents of children with SMA and healthcare professionals in Sweden note the many ways the pandemic affected ...
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FDA Approves Journavx, New Nonopioid Med, for Acute Pain
The FDA recently approved Vertex Pharmaceuticals Incorporated’s Journavx (suzetrigine), a first-in-class non-opioid ...
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Biogen’s higher dose spinal muscular atrophy regimen accepted for review by EMA/FDA
Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started reviewing a higher dose regimen of its spinal muscular atrophy (SMA) treatment ...
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the United States and Europe have accepted applications for a higher dose regimen ...
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Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
Biogen Inc. announced that the FDA has accepted and the EMA has validated its supplemental New Drug Application for a higher dose regimen of nusinersen, intended for treating spinal muscular ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMACAMBRIDGE, Mass., Jan. 23 ...
Nasdaq21d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE ...
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FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved nusiner ...