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