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

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.

Biogen's treatment for neurodegenerative disorder spinal muscular atrophy (SMA) Spinraza has come under pressure in an increasingly competitive market, but the company hopes a new high-dose ...