Novartis set to answer inclisiran’s FDA rebuff by Q3. But what about an approval timeline?
Novartis bought cholesterol drug inclisiran on the brink of a new drug filing as the centerpiece of its $9.7 billion acquisition of The Medicines Company....
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FDA rebuffs Novartis’ cholesterol drug inclisiran in an ‘inspection-related’ approval delay
Manufacturing inspection-related woes have derailed another FDA approval this year, this time for a drug at the center of a $9.7 billion acquisition. Novartis’ cholesterol drug inclisiran...