US FDA accepts MS drug Lemtrada resubmission for review
US FDA accepts MS drug Lemtrada resubmission for review
The US Food and Drug Administration (FDA) has accepted for review the Genzyme's resubmission of supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter...... Read More - http://www.ms-uk.org/lemtrada
MS-UK - http://www.ms-uk.org/
-
- Similar Topics
- Replies
- Views
- Last post
-
- 0 Replies
- 1818 Views
-
Last post by frodo
-
- 0 Replies
- 1164 Views
-
Last post by NHE
-
- 0 Replies
- 1631 Views
-
Last post by frodo
-
- 0 Replies
- 1159 Views
-
Last post by frodo
-
- 1 Replies
- 1589 Views
-
Last post by frodo
-
- 0 Replies
- 1944 Views
-
Last post by NHE
-
- 0 Replies
- 2206 Views
-
Last post by NHE
-
- 0 Replies
- 1005 Views
-
Last post by frodo
-
- 1 Replies
- 1321 Views
-
Last post by NHE