After delay caused by Italian CDMO, Novartis moves manufacturing to Austrian site

After the FDA handed Novartis a complete response letter for its PCSK9 drug inclisiran in December due to manufacturing deficiencies with its Italian CDMO partner, the company has resubmitted its application after switching to its own manufacturing site in Schaftenau, Austria.

The site in Schaftenau will start production following...

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