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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 14 days apart can deliver significant clinical benefits in patients with spinal muscular atrophy.

Hosted on MSN · 3d

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 of its spinal muscular atrophy (SMA) drug,

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

Zacks.com on MSN · 2d

FDA & EMA Accept Biogen's Filings for Higher Dose SMA Drug

Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings seeking label expansion for a higher dose of its blockbuster spinal muscular atrophy (SMA) drug Spinraza. This new proposed dosing regimen simplifies administration by offering two initial 50 mg doses spaced 14 days apart,

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 ...

GlobalData on MSN3d

Biogen’s higher dose Spinraza under review by US and EU regulators

Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.

Managed Healthcare Executive3d

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 ...

IFLScience on MSN3d

New Breast Cancer Drug Kills Mouse Tumors In Single Dose

More testing is needed, but if the same results are seen in humans, it could transform treatment of the disease.

Biogen Gets U.S., European Reviews of Higher-Dose Spinraza

Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...

BioSpace3d

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 ...

News Medical2d

Low-dose initiation of buprenorphine for people using fentanyl fails to deliver expected results

During the COVID-19 pandemic, when fentanyl overdoses surged, doctors were desperate to find ways of helping their patients.

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