FDA-related information through December 2007 on Guaifenesin/codeine extended-release, delayed-release valproic acid, telavancin, Endeavor, oral beclomethasone, and R7128
Approvable designations
Recommendation for approval
Nonapprovable designation
Orphan drug designations
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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