Brief: Calliditas Therapeutics AB Reports PDUFA Goal Date Extension For Nefecon NDA In U.S.

Calliditas Therapeutics AB

14/09/2021 20:13

Sept 14 (Reuters) - Calliditas Therapeutics AB  CALTX.ST :
    * CALLIDITAS THERAPEUTICS AB  CALTX.ST  - PDUFA GOAL DATE
EXTENSION FOR NEFECON NDA IN U.S.
    * CALLIDITAS THERAPEUTICS AB  CALTX.ST  - FDA HAS EXTENDED
PDUFA
GOAL DATE TO DECEMBER 15, 2021 
    * CALLIDITAS THERAPEUTICS AB -IN ITS REVIEW OF NDA, FDA HAS
REQUESTED FURTHER ANALYSES OF NEFLGARD TRIAL DATA WHICH CO HAS
PROVIDED TO FDA 

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