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 Development Unit at Biogen.
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.
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 its Ionis-partnered therapy Spinraza for spinal muscular atrophy will be considered by the FDA and EMA.
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Investing.com -- 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, nusinersen.
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
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 ...
dermatologyadvisor2d
Monthly Tralokinumab Is an Effective Dosing Regimen in Atopic Dermatitis
Monthly tralokinumab is an effective dosing regimen for patients with atopic dermatitis who have achieved stable disease control.
IFLScience on MSN2d
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.