Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...

compared to those who received a sham procedure. Other approved treatments include Biogen's spinal injection Spinraza, and Roche-PTC Therapeutics' oral drug Evrysdi. SMA is the leading genetic ...

Biogen said U.S. and European regulators will review its applications seeking approval of a higher-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy.