Managed Healthcare Executive5d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines ...
Pharm Exec4d
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 ...
Nasdaq5d
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 ...
The Pharma Letter5d
FDA and EMA accept filings for higher dose of nusinersen in SMA
The US Food and Drug Administration (FDA) has accepted Biogen’s supplemental New Drug Application (sNDA) and the European ...
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 ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
BioSpace5d
Biogen Trims Research Workforce, Higher-Dose SMA Drug Accepted for Regulatory Review
In a good-news-bad-news week for Biogen, the company will cut an undisclosed number of employees, just as a higher dose of ...
Scholar Rock Sets Sights on $2 Billion Apitegromab Revenue Amid Spinal Muscular Atrophy Market Growth
Scholar Rock aims for a 2025 launch of apitegromab in SMA, expecting $2 billion in global revenue and significant growth from upcoming trials and favorable data.
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...
Nasdaq5d
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 ...