Brief: Bioarctic Says FDA Accepts Biologics License Application For Subcutaneous Maintenance Dosing Of Leqembi In US

BioArctic AB

14/01/2025 24:01

Jan 13 (Reuters) - BioArctic AB  BIOAb.ST :
    * FDA ACCEPTS BIOLOGICS LICENSE APPLICATION FOR SUBCUTANEOUS
MAINTENANCE DOSING OF LEQEMBI® (LECANEMAB-IRMB) IN THE US
    * PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE HAS
BEEN SET
TO AUGUST 31, 2025.

Source text:  ID:nWkr5Jj6ZW 
Further company coverage:  BIOAb.ST 

 ((Reuters.Briefs@thomsonreuters.com;))