At least seven PDUFA dates on deck in February

At least seven therapies have PDUFA dates in February, five of which are under priority review.

FDA is slated to make its first decision of the month on Feb. 5 on a priority review of a BLA for sutimlimab from  Sanofi (Euronext:SAN; NASDAQ:SNY) to treat cold agglutinin disease. Sanofi resubmitted its BLA for the anti-C1S mAb in 3Q21 following FDA’s complete response letter citing deficiencies identified during an inspection of a third-party manufacturing facility. Sutimlimab has breakthrough therapy designation and orphan drug designation. ...