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Keeping Track Of Approvals: Two Novel Drugs (Givlaari And Xcopri), A Project Orbis Collaboration (Calquence) And Another Humira Biosimilar

 
• By Michael Cipriano

The latest news on US FDA drug approvals.

Keeping Track Feature image

For the third straight year, the US Food and Drug Administration has reached a mark of at least 40 approvals of novel drugs and therapeutic biologics after greenlighting Alnylam Pharmaceuticals Inc.'s Givlaari (givosiran) SK Life Science Inc.'s Xcopri (cenobamate) for the US market.

A major supplemental approval went to AstraZeneca PLC's Calquence (acalabrutinib) for a chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) indication, which was cleared under the FDA's Project Orbis and...

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