Recent FDA action (through August 2009) related to trazodone, casopitant, sertindole, alogliptin, bepotastine, trabectedin, and velaglucerase alfa
Complete response
Recommended for approval
Not recommended for approval
Priority review
Orphan drug designation
FDA and EMA Accepts Applications for New Nusinersen Regimen
January 23rd 2025An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
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