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Nusinersen, 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 · 22h

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 · 1d

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 Development Unit at Biogen.

The Pharma Letter · 1d

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,

23hon 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 ...

SMA3h

US, EU regulators to review higher-dose Spinraza for use in SMA

Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...

Nature3y

The expanding frontier of nucleic acid therapeutics

For example, Biogen’s nusinersen, an ASO therapy for the fatal neuromuscular condition spinal muscular atrophy (SMA), can reduce by half the likelihood of death or the need for mechanical ...

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 ...

SMA2d

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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