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 ...
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 ...
Biogen announces FDA, EMA accepted applications for higher dose of nusinersen
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA, ...
Biogen Inc.: 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 regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
The Pharma Letter2d
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 ...
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 ...
Mena FN3d
FDA And EMA Accept Applications For Higher Dose Regimen Of Nusinersen In SMA
Biogen Safe Harbor This news release contains forward-looking statements, including related to the potential clinical effects of a higher dose regimen of nusinersen; the potential benefits ...
Morningstar3d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Nusinersen is currently commercialized under ... which have been observed after administration of some ASOs. Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA ...