Nasdaq17d
Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
for a higher dose regimen of nusinersen highlights Biogen's ongoing commitment to advancing treatment options for spinal muscular atrophy (SMA). The new dosing regimen has the potential to offer ...
Pharm Exec16d
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
Nasdaq17d
Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA). The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg ...
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 ...
Healio6d
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
PMLiVE12d
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 ...
Hosted on MSN27d
Broader population could benefit from Novartis spinal muscular atrophy treatment
These include Biogen’s once-quarterly IT administration of Spinraza (nusinersen ... the growing market in its recent report, Spinal Muscular Atrophy: Opportunity Assessment and Forecast ...
WUNC3d
Spinal stimulation restored muscles wasted by rare genetic disorder
Three patients with spinal muscular atrophy had improved muscle strength and could walk farther after a month of daily spinal stimulation.
SunLive5d
Newborn screenings for spinal muscular atrophy
From February 12, all newborn babies will be offered screening for spinal muscular atrophy (SMA), a rare progressive neuromuscular disease. SMA will be one of more than 20 other rare disorders ...
Benzinga.com25d
Scholar Rock Sets Sights on $2 Billion Apitegromab Revenue Amid Spinal Muscular Atrophy Market Growth
The discussions mainly focused on apitegromab for spinal muscular atrophy (SMA), including its ... ambulatory type 2/3 SMA treated with Spinraza (nusinersen) or Evrysdi (risdiplam), are expected ...
NZ Doctor5d
Newborn screening for spinal muscular atrophy to begin next week
From February 12, all newborn babies will be offered screening for spinal muscular atrophy (SMA), a rare progressive neuromuscular disease. SMA will be one of more than 20 other rare disorders ...