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Biogen, Nusinersen and new drug application

FDA and EMA review Biogen's higher dose SMA drug

CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, has reached a pivotal phase as regulatory agencies in the United States and Europe are now reviewing a higher dose regimen of nusinersen,

Managed Healthcare Executive · 2d

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 Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.

Business Insider · 3d

Biogen Says FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA

Biogen Inc. (BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New

The Pharma Letter · 3d

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 Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen,

Pharm Exec1d

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 ...

2don MSN

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 ...

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 ...

SMA4d

Woman gives birth to healthy child while on Spinraza treatment

A woman with SMA type 3 became pregnant while on Spinraza treatment and gave birth to a healthy child, per a case report.

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Biogen, Nusinersen and new drug application

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