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Regulatory Affairs

Clinical Research European Medicines Agency FDA Submissions Japan Ministry of Health Clinical Applications European Commission FDA Approval Process

Moonlake Shares Plunge on Mixed Phase 3 Results for Hidradenitis Drug

Analysts question the approval path, citing mixed efficacy alongside a high placebo response.

European Commission Approves Voranigo for IDH-Mutant Grade 2 Glioma

Jaypirca Delivers Significant PFS Benefit Over Chemoimmunotherapy in First-Line CLL/SLL