Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape
Executive Summary
Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.
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