Healio4d
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
Pharm Exec14d
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 ...
SMA14d
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 regimen for SMA.
Yahoo Finance14d
FDA & EMA Accept Biogen's Filings for Higher Dose SMA Drug
which achieved its primary endpoint of statistically significant improvement in motor function in infants with SMA treated with a higher dose of Spinraza. Per management, a higher dose regimen of ...
Investing14d
FDA and EMA review Biogen's higher dose SMA drug
has reached a pivotal phase as regulatory agencies in the United States and Europe are now reviewing a higher dose regimen of nusinersen, a drug designed to treat spinal muscular atrophy (SMA). The ...
Taiwan News14d
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
2 SPINRAZA has shown sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years, 3,4 combined with unsurpassed real-world ...
Nasdaq15d
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 ...