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Biogen’s higher dose Spinraza under review by US and EU regulators
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Biogen’s applications for a higher dose regimen of spinal muscular atrophy (SMA) treatment Spinraza ...
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US/EU regulators start review of Biogen's high-dose Spinraza
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 ...