Novo Nordisk’s Hemophilia B Drug Faces Safety Scrutiny By US FDA Panel
Novo’s long-acting coagulation Factor IX showed polyethylene glycol (PEG) accumulation in the choroid plexus of animals, potentially raising a neurological safety issue when used in humans, FDA says ahead of Blood Products Advisory Committee review.
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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) meets monthly to review applications for centralized EU marketing authorization. Here’s a summary of their March 2017 recommendations.