FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
Nasdaq13d
Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
Nusinersen, marketed as SPINRAZA, targets the underlying cause of SMA and has been widely used globally. The FDA acceptance and EMA validation of the supplemental New Drug Application (sNDA ...
The Pharma Letter13d
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 ...
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 ...
Nasdaq13d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Nusinersen is currently commercialized under the brand name SPINRAZA in over 71 countries at the label-approved dose of 12 mg. About the DEVOTE StudyDEVOTE was a Phase 2/3 randomized, controlled ...
Morningstar13d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Nusinersen is currently commercialized under the brand name SPINRAZA in over 71 countries at the label-approved dose of 12 mg. “Continued progress to improve upon the remarkable initial ...
SunLive16h
Newborn screenings for spinal muscular atrophy
From February 12, all newborn babies will be offered screening for spinal muscular atrophy (SMA), a rare progressive neuromuscular disease. SMA will be one of more than 20 other rare disorders ...
Pharm Exec12d
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 ...
Toronto Star13d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
compared to the approved nusinersen regimen (SPINRAZA®). “We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe ...