Regulatory & Policy
FDA Grants Orphan Drug Status to Low-Sodium Oxybate for Sleep Disorder
The designation hinges on a plausible clinical superiority argument over existing oxybate therapies — a regulatory path…
Regulatory & Policy 2 stories
Regulatory & Policy
Isupartob Sodium Earns FDA Fast Track for Sepsis Indication
Fast Track status enables rolling review and closer FDA collaboration — a potential signal for future nutraceutical-adj…